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A Single Rising Dose Study of MK-8150 (MK-8150-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590810
Recruitment Status : Completed
First Posted : May 3, 2012
Results First Posted : June 27, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Hypertension
Isolated Systolic Hypertension (ISH)
Interventions Drug: MK-8150 2.0 mg
Drug: MK-8150 10 mg
Drug: MK-8150 40 mg
Drug: MK-8150 90 mg
Drug: MK-8150 5.0 mg
Drug: MK-8150 20 mg
Drug: MK-8150 60 mg
Drug: MK-8150 120 mg
Drug: MK-8150 160 mg
Drug: MK-8150 320 mg
Drug: MK-8150 600 mg
Drug: MK-8150 900 mg
Drug: MK-8150 1200 mg
Drug: Placebo for MK-8150
Drug: MK-8150 50 mg
Drug: MK-8150 100 mg
Drug: MK-8150 200 mg
Drug: MK-8150 400 mg
Drug: MK-8150 500 mg
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Panel A – MK-8150 2 to 90 mg/Placebo Panel B – MK-8150 4 to 120 mg/Placebo Panel C – MK-8150 5 to 90 mg/Placebo Panel D – MK-8150 50 to 200 mg Panel D – Placebo
Hide Arm/Group Description Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg. Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg. Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg. Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg. Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
Period Title: Overall Study
Started 8 8 8 8 2
Completed 8 7 7 8 2
Not Completed 0 1 1 0 0
Reason Not Completed
Physician Decision             0             1             1             0             0
Arm/Group Title Panel A – MK-8150 2 to 90 mg/Placebo Panel B – MK-8150 4 to 120 mg/Placebo Panel C – MK-8150 5 to 90 mg/Placebo Panel D – MK-8150 50 to 200 mg Panel D – Placebo Total
Hide Arm/Group Description Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg. Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg. Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg. Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg. Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo. Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 8 2 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 8 participants 2 participants 34 participants
37.5  (9.8) 34.8  (8.0) 51.4  (6.8) 44.1  (6.9) 39.0  (12.7) 42  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 2 participants 34 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
2
 100.0%
34
 100.0%
Central Systolic Blood Pressure (cSBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 8 participants 8 participants 8 participants 8 participants 2 participants 34 participants
98  (7) 98  (6) 125  (8) 102  (9) 105  (6) 106  (13)
Augmentation Index (AIx)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of central pulse pressure
Number Analyzed 8 participants 8 participants 8 participants 8 participants 2 participants 34 participants
7  (3) 8  (4) 22  (8) 10  (11) 8  (12) 12  (9)
[1]
Measure Description: AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. AIx is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness.
Heart Rate (HR)  
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 8 participants 8 participants 8 participants 8 participants 2 participants 34 participants
58  (7) 54  (5) 67  (9) 61  (7) 45  (1) 59  (9)
Central Diastolic Blood Pressure (cDBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 8 participants 8 participants 8 participants 8 participants 2 participants 34 participants
85  (6) 84  (6) 107  (6) 86  (8) 91  (6) 91  (11)
Peripheral Systolic Blood Pressure (pSBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 8 participants 8 participants 8 participants 8 participants 2 participants 34 participants
119  (5) 119  (6) 148  (7) 125  (8) 126  (12) 128  (14)
Peripheral Diastolic Blood Pressure (pDBP)  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 8 participants 8 participants 8 participants 8 participants 2 participants 34 participants
75  (6) 73  (6) 94  (6) 75  (8) 80  (7) 79  (10)
1.Primary Outcome
Title Number of Participants With an Adverse Event (AE)
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
Time Frame Up to 14 days after the last dose (Up to approximately 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of study drug
Arm/Group Title Panel A – MK-8150 2 to 90 mg/Placebo Panel B – MK-8150 4 to 120 mg/Placebo Panel C – MK-8150 5 to 90 mg/Placebo Panel D – MK-8150 50 to 200 mg Panel D – Placebo
Hide Arm/Group Description:
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
Overall Number of Participants Analyzed 8 8 8 8 2
Measure Type: Number
Unit of Measure: participants
8 8 7 7 2
2.Primary Outcome
Title Number of Participants Who Discontinued Study Due to an AE
Hide Description An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
Time Frame Up to 14 days after the last dose (Up to approximately 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of study drug
Arm/Group Title Panel A – MK-8150 2 to 90 mg/Placebo Panel B – MK-8150 4 to 120 mg/Placebo Panel C – MK-8150 5 to 90 mg/Placebo Panel D – MK-8150 50 to 200 mg Panel D – Placebo
Hide Arm/Group Description:
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
Overall Number of Participants Analyzed 8 8 8 8 2
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
3.Primary Outcome
Title Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
Hide Description cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel A – MK-8150 2 mg Panel A – MK-8150 6 mg Panel A – MK-8150 24 mg Panel A – MK-8150 24 mg (Fed Condition) Panel A – MK-8150 90 mg Panel A – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 2 mg
Single dose of MK-8150 6 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 6 6 8
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
1.33  (0.99) -1.65  (1.31) -7.69  (1.71) -6.29  (1.82) -9.86  (1.66) 0.55  (1.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 2 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.503
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
-1.59 to 3.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.15
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 6 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.20
Confidence Interval (2-Sided) 95%
-2.86 to -1.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.32
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.23
Confidence Interval (2-Sided) 95%
-10.13 to -6.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.92
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg (Fed Condition), Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.84
Confidence Interval (2-Sided) 95%
-9.10 to -4.58
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.10
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 90 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.41
Confidence Interval (2-Sided) 95%
-12.89 to -7.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.21
Estimation Comments Difference is MK-8150 dose – placebo
4.Primary Outcome
Title Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
Hide Description cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel B – MK-8150 4 mg Panel B – MK-8150 12 mg Panel B – MK-8150 45 mg Panel B – MK-8150 120 mg Panel B – MK-8150 120 mg (Repeat Dose) Panel B – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 4 mg
Single dose of MK-8150 12 mg
Single dose of MK-8150 45 mg
Single dose of MK-8150 120 mg
Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 5 5 8
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-5.06  (0.91) -7.64  (1.50) -11.67  (1.68) -14.20  (1.60) -11.91  (1.26) -2.18  (1.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 4 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.89
Confidence Interval (2-Sided) 95%
-5.79 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.40
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 12 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.46
Confidence Interval (2-Sided) 95%
-9.49 to -1.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.95
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 45 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.49
Confidence Interval (2-Sided) 95%
-14.20 to -4.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.27
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 120 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -12.02
Confidence Interval (2-Sided) 95%
-16.51 to -7.52
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.17
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 120 mg (Repeat Dose), Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.73
Confidence Interval (2-Sided) 95%
-12.93 to -6.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.55
Estimation Comments Difference is MK-8150 dose – placebo
5.Primary Outcome
Title Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
Hide Description cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population
Arm/Group Title Panel C – MK-8150 5 mg Panel C – MK-8150 24 mg Panel C – MK-8150 90 mg Panel C – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 5 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 5 5 6 6
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-11.69  (3.01) -18.38  (4.47) -25.11  (3.20) -7.60  (4.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 5 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.480
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.10
Confidence Interval (2-Sided) 95%
-16.44 to 8.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.61
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 24 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.79
Confidence Interval (2-Sided) 95%
-23.37 to 1.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.72
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 90 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -17.51
Confidence Interval (2-Sided) 95%
-28.85 to -6.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.15
Estimation Comments Difference is MK-8150 dose – placebo
6.Primary Outcome
Title Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
Hide Description cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
Arm/Group Title Panel D – MK-8150 50 mg Panel D – MK-8150 50 mg (Repeat Dose) Panel D – MK-8150 100 mg Panel D – MK-8150 200 mg Panel D – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 50 mg
Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
Single dose of MK-8150 100 mg
Single dose of MK-8150 200 mg
Single dose of placebo
Overall Number of Participants Analyzed 8 8 8 8 2
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-16.23  (1.40) -13.22  (1.55) -15.84  (1.50) -15.86  (1.47) -3.02  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 50 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -13.21
Confidence Interval (2-Sided) 95%
-16.84 to -9.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.74
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 50 mg (Repeat Dose), Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.20
Confidence Interval (2-Sided) 95%
-13.94 to -6.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.80
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 100 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -12.82
Confidence Interval (2-Sided) 95%
-16.45 to -9.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.74
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 200 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -12.84
Confidence Interval (2-Sided) 95%
-16.49 to -9.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.75
Estimation Comments Difference is MK-8150 dose – placebo
7.Primary Outcome
Title Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
Hide Description AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose; except Period 1: Pre-dose and 2, 4, 12 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel A – MK-8150 2 mg Panel A – MK-8150 6 mg Panel A – MK-8150 24 mg Panel A – MK-8150 24 mg (Fed Condition) Panel A – MK-8150 90 mg Panel A – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 2 mg
Single dose of MK-8150 6 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 6 6 8
Least Squares Mean (Standard Error)
Unit of Measure: percentage of central pulse pressure
-0.75  (1.99) -0.67  (1.63) -10.06  (1.62) -6.59  (2.22) -15.22  (1.53) 1.56  (1.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 2 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.31
Confidence Interval (2-Sided) 95%
-4.73 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.18
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 6 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.23
Confidence Interval (2-Sided) 95%
-4.00 to -0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.86
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -11.62
Confidence Interval (2-Sided) 95%
-14.42 to -8.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.36
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg (Fed Condition), Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.15
Confidence Interval (2-Sided) 95%
-11.34 to -4.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.55
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 90 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -16.78
Confidence Interval (2-Sided) 95%
-20.81 to -12.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.96
Estimation Comments Difference is MK-8150 dose – placebo
8.Primary Outcome
Title Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
Hide Description AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel B – MK-8150 4 mg Panel B – MK-8150 12 mg Panel B – MK-8150 45 mg Panel B – MK-8150 120 mg Panel B – MK-8150 120 mg (Repeat Dose) Panel B – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 4 mg
Single dose of MK-8150 12 mg
Single dose of MK-8150 45 mg
Single dose of MK-8150 120 mg
Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 5 5 8
Least Squares Mean (Standard Error)
Unit of Measure: percentage of central pulse pressure
-3.04  (1.55) -6.85  (1.83) -13.57  (2.54) -18.42  (1.55) -16.33  (2.22) -0.09  (1.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 4 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.95
Confidence Interval (2-Sided) 95%
-5.56 to -0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.26
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 12 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.76
Confidence Interval (2-Sided) 95%
-11.29 to -2.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.19
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 45 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -13.48
Confidence Interval (2-Sided) 95%
-20.03 to -6.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.16
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 120 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -18.33
Confidence Interval (2-Sided) 95%
-21.98 to -14.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.76
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 120 mg (Repeat Dose), Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -16.24
Confidence Interval (2-Sided) 95%
-20.29 to -12.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.96
Estimation Comments Difference is MK-8150 dose – placebo
9.Primary Outcome
Title Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
Hide Description AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population
Arm/Group Title Panel C – MK-8150 5 mg Panel C – MK-8150 24 mg Panel C – MK-8150 90 mg Panel C – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 5 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 5 5 6 6
Least Squares Mean (Standard Error)
Unit of Measure: percentage of central pulse pressure
-8.32  (1.69) -12.09  (3.25) -21.03  (1.90) -6.73  (2.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 5 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.539
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.59
Confidence Interval (2-Sided) 95%
-7.12 to 3.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.51
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 24 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.36
Confidence Interval (2-Sided) 95%
-12.23 to 1.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.12
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 90 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -14.30
Confidence Interval (2-Sided) 95%
-19.69 to -8.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.45
Estimation Comments Difference is MK-8150 dose – placebo
10.Primary Outcome
Title Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
Hide Description AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
Arm/Group Title Panel D – MK-8150 50 mg Panel D – MK-8150 50 mg (Repeat Dose) Panel D – MK-8150 100 mg Panel D – MK-8150 200 mg Panel D – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 50 mg
Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
Single dose of MK-8150 100 mg
Single dose of MK-8150 200 mg
Single dose of placebo
Overall Number of Participants Analyzed 8 8 8 8 2
Least Squares Mean (Standard Error)
Unit of Measure: percentage of central pulse pressure
-13.83  (1.54) -12.04  (1.46) -15.09  (1.12) -14.42  (1.29) -1.46  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 50 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -12.36
Confidence Interval (2-Sided) 95%
-15.62 to -9.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.56
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 50 mg (Repeat Dose), Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.58
Confidence Interval (2-Sided) 95%
-13.74 to -7.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.51
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 100 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -13.63
Confidence Interval (2-Sided) 95%
-16.12 to -11.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.20
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 200 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -12.96
Confidence Interval (2-Sided) 95%
-15.85 to -10.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.38
Estimation Comments Difference is MK-8150 dose – placebo
11.Primary Outcome
Title Change From Baseline in Time-weighted Average Across 12 Hours (TWA0-12hrs) HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
Hide Description HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel A – MK-8150 2 mg Panel A – MK-8150 6 mg Panel A – MK-8150 24 mg Panel A – MK-8150 24 mg (Fed Condition) Panel A – MK-8150 90 mg Panel A – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 2 mg
Single dose of MK-8150 6 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 6 6 8
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute
2.94  (1.31) 4.08  (1.61) 4.07  (1.47) 7.54  (2.19) 4.04  (1.65) 1.89  (1.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 2 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
-0.50 to 2.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.75
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 6 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.18
Confidence Interval (2-Sided) 95%
-0.25 to 4.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.18
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.18
Confidence Interval (2-Sided) 95%
1.04 to 3.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.55
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg (Fed Condition), Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.64
Confidence Interval (2-Sided) 95%
3.14 to 8.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.22
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 90 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.15
Confidence Interval (2-Sided) 95%
0.63 to 3.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.74
Estimation Comments Difference is MK-8150 dose – placebo
12.Primary Outcome
Title Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
Hide Description HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel B – MK-8150 4 mg Panel B – MK-8150 12 mg Panel B – MK-8150 45 mg Panel B – MK-8150 120 mg Panel B – MK-8150 120 mg (Repeat Dose) Panel B – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 4 mg
Single dose of MK-8150 12 mg
Single dose of MK-8150 45 mg
Single dose of MK-8150 120 mg
Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 5 5 8
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute
-0.26  (1.10) -0.91  (1.57) 0.66  (1.75) 3.17  (0.91) 5.19  (1.45) 0.57  (1.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 4 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.557
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-3.70 to 2.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.39
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 12 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.48
Confidence Interval (2-Sided) 95%
-3.65 to 0.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.05
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 45 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.951
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-3.04 to 3.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.52
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 120 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.61
Confidence Interval (2-Sided) 95%
1.34 to 3.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.61
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 120 mg (Repeat Dose), Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.62
Confidence Interval (2-Sided) 95%
3.00 to 6.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.78
Estimation Comments Difference is MK-8150 dose – placebo
13.Primary Outcome
Title Change From Baseline in TWA0-12hrs HR in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
Hide Description HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population
Arm/Group Title Panel C – MK-8150 5 mg Panel C – MK-8150 24 mg Panel C – MK-8150 90 mg Panel C – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 5 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 5 5 6 6
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute
-6.11  (2.32) -3.74  (1.58) -1.02  (1.75) -4.67  (2.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 5 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.241
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.45
Confidence Interval (2-Sided) 95%
-4.01 to 1.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.16
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 24 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.664
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
-3.63 to 5.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.07
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 90 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.114
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.65
Confidence Interval (2-Sided) 95%
-1.03 to 8.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.13
Estimation Comments Difference is MK-8150 dose – placebo
14.Primary Outcome
Title Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
Hide Description HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
Arm/Group Title Panel D – MK-8150 50 mg Panel D – MK-8150 50 mg (Repeat Dose) Panel D – MK-8150 100 mg Panel D – MK-8150 200 mg Panel D – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 50 mg
Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
Single dose of MK-8150 100 mg
Single dose of MK-8150 200 mg
Single dose of placebo
Overall Number of Participants Analyzed 8 8 8 8 2
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute
-1.24  (1.90) -1.09  (2.15) -0.52  (1.59) 3.83  (2.15) -5.67  (3.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 50 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.385
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.42
Confidence Interval (2-Sided) 95%
-5.96 to 14.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.98
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 50 mg (Repeat Dose), Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.385
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.58
Confidence Interval (2-Sided) 95%
-6.16 to 15.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.15
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 100 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.276
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 5.15
Confidence Interval (2-Sided) 95%
-4.44 to 14.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.60
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 200 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 9.50
Confidence Interval (2-Sided) 95%
-0.81 to 19.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.94
Estimation Comments Difference is MK-8150 dose – placebo
15.Primary Outcome
Title Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
Hide Description cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel A – MK-8150 2 mg Panel A – MK-8150 6 mg Panel A – MK-8150 24 mg Panel A – MK-8150 24 mg (Fed Condition) Panel A – MK-8150 90 mg Panel A – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 2 mg
Single dose of MK-8150 6 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 6 6 8
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
0.74  (1.07) -1.97  (1.46) -8.34  (1.77) -6.73  (2.27) -10.54  (1.62) -0.23  (1.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 2 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.383
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
-1.28 to 3.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.09
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 6 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.75
Confidence Interval (2-Sided) 95%
-2.79 to -0.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.51
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.11
Confidence Interval (2-Sided) 95%
-10.08 to -6.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.96
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg (Fed Condition), Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.50
Confidence Interval (2-Sided) 95%
-9.74 to -3.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.58
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 90 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.31
Confidence Interval (2-Sided) 95%
-12.84 to -7.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.23
Estimation Comments Difference is MK-8150 dose – placebo
16.Primary Outcome
Title Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
Hide Description cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel B – MK-8150 4 mg Panel B – MK-8150 12 mg Panel B – MK-8150 45 mg Panel B – MK-8150 120 mg Panel B – MK-8150 120 mg (Repeat Dose) Panel B – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 4 mg
Single dose of MK-8150 12 mg
Single dose of MK-8150 45 mg
Single dose of MK-8150 120 mg
Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 5 5 8
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-5.02  (1.10) -7.76  (1.61) -11.88  (1.75) -14.12  (1.95) -12.21  (1.30) -2.96  (1.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 4 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.216
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.07
Confidence Interval (2-Sided) 95%
-5.43 to 1.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.62
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 12 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.80
Confidence Interval (2-Sided) 95%
-9.51 to -0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.27
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 45 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.93
Confidence Interval (2-Sided) 95%
-14.10 to -3.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.50
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 120 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -11.16
Confidence Interval (2-Sided) 95%
-16.64 to -5.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.65
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 120 mg (Repeat Dose), Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.25
Confidence Interval (2-Sided) 95%
-12.70 to -5.80
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.67
Estimation Comments Difference is MK-8150 dose – placebo
17.Primary Outcome
Title Change From Baseline in TWA0-24hrs cDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
Hide Description cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population
Arm/Group Title Panel C – MK-8150 5 mg Panel C – MK-8150 24 mg Panel C – MK-8150 90 mg Panel C – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 5 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 5 5 6 6
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-10.40  (1.96) -16.32  (3.97) -23.65  (2.67) -8.14  (3.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 5 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.635
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.27
Confidence Interval (2-Sided) 95%
-12.50 to 7.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.65
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 24 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.18
Confidence Interval (2-Sided) 95%
-19.58 to 3.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.18
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 90 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -15.51
Confidence Interval (2-Sided) 95%
-25.01 to -6.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.32
Estimation Comments Difference is MK-8150 dose – placebo
18.Primary Outcome
Title Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
Hide Description cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
Arm/Group Title Panel D – MK-8150 50 mg Panel D – MK-8150 50 mg (Repeat Dose) Panel D – MK-8150 100 mg Panel D – MK-8150 200 mg Panel D – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 50 mg
Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
Single dose of MK-8150 100 mg
Single dose of MK-8150 200 mg
Single dose of placebo
Overall Number of Participants Analyzed 8 8 8 8 2
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-15.55  (1.05) -13.26  (0.93) -15.35  (1.19) -15.84  (1.10) -4.71  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 50 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.84
Confidence Interval (2-Sided) 95%
-13.79 to -7.89
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.42
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 50 mg (Repeat Dose), Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.55
Confidence Interval (2-Sided) 95%
-11.18 to -5.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.26
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 100 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.64
Confidence Interval (2-Sided) 95%
-13.44 to -7.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.34
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 200 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -11.13
Confidence Interval (2-Sided) 95%
-13.97 to -8.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.36
Estimation Comments Difference is MK-8150 dose – placebo
19.Primary Outcome
Title Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
Hide Description pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel A – MK-8150 2 mg Panel A – MK-8150 6 mg Panel A – MK-8150 24 mg Panel A – MK-8150 24 mg (Fed Condition) Panel A – MK-8150 90 mg Panel A – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 2 mg
Single dose of MK-8150 6 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 6 6 8
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
0.73  (1.35) -0.24  (1.45) -3.13  (1.56) -1.91  (1.42) -4.46  (1.70) 1.46  (1.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 2 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.547
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-3.19 to 1.73
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.19
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 6 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.70
Confidence Interval (2-Sided) 95%
-2.79 to -0.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.53
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.59
Confidence Interval (2-Sided) 95%
-6.23 to -2.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.80
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg (Fed Condition), Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.37
Confidence Interval (2-Sided) 95%
-4.98 to -1.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.78
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 90 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.92
Confidence Interval (2-Sided) 95%
-8.24 to -3.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.13
Estimation Comments Difference is MK-8150 dose – placebo
20.Primary Outcome
Title Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
Hide Description pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel B – MK-8150 4 mg Panel B – MK-8150 12 mg Panel B – MK-8150 45 mg Panel B – MK-8150 120 mg Panel B – MK-8150 120 mg (Repeat Dose) Panel B – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 4 mg
Single dose of MK-8150 12 mg
Single dose of MK-8150 45 mg
Single dose of MK-8150 120 mg
Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 5 5 8
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-4.61  (1.00) -6.81  (1.61) -7.16  (2.00) -8.50  (1.39) -6.40  (1.19) -1.17  (1.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 4 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.43
Confidence Interval (2-Sided) 95%
-6.19 to -0.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.33
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 12 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.64
Confidence Interval (2-Sided) 95%
-8.43 to -2.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.35
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 45 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.99
Confidence Interval (2-Sided) 95%
-9.94 to -2.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.91
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 120 mg, Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.33
Confidence Interval (2-Sided) 95%
-10.90 to -3.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.73
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Panel B – MK-8150 120 mg (Repeat Dose), Panel B – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.22
Confidence Interval (2-Sided) 95%
-7.76 to -2.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.22
Estimation Comments Difference is MK-8150 dose – placebo
21.Primary Outcome
Title Change From Baseline in TWA0-24hrs pSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
Hide Description pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population
Arm/Group Title Panel C – MK-8150 5 mg Panel C – MK-8150 24 mg Panel C – MK-8150 90 mg Panel C – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 5 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 5 5 6 6
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-12.32  (3.88) -18.26  (4.84) -21.42  (3.63) -5.39  (6.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 5 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.311
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.93
Confidence Interval (2-Sided) 95%
-21.27 to 7.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.52
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 24 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -12.87
Confidence Interval (2-Sided) 95%
-27.44 to 1.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.62
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel C – MK-8150 90 mg, Panel C – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -16.03
Confidence Interval (2-Sided) 95%
-29.87 to -2.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.29
Estimation Comments Difference is MK-8150 dose – placebo
22.Primary Outcome
Title Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
Hide Description pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
Arm/Group Title Panel D – MK-8150 50 mg Panel D – MK-8150 50 mg (Repeat Dose) Panel D – MK-8150 100 mg Panel D – MK-8150 200 mg Panel D – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 50 mg
Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
Single dose of MK-8150 100 mg
Single dose of MK-8150 200 mg
Single dose of placebo
Overall Number of Participants Analyzed 8 8 8 8 2
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-12.77  (1.14) -10.19  (1.86) -11.19  (1.78) -10.47  (1.79) -3.00  (0.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 50 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.77
Confidence Interval (2-Sided) 95%
-12.90 to -6.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.50
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 50 mg (Repeat Dose), Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.19
Confidence Interval (2-Sided) 95%
-11.57 to -2.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.10
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 100 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.19
Confidence Interval (2-Sided) 95%
-12.40 to -3.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.02
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel D – MK-8150 200 mg, Panel D – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.47
Confidence Interval (2-Sided) 95%
-11.69 to -3.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.02
Estimation Comments Difference is MK-8150 dose – placebo
23.Primary Outcome
Title Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
Hide Description pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Time Frame Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
Arm/Group Title Panel A – MK-8150 2 mg Panel A – MK-8150 6 mg Panel A – MK-8150 24 mg Panel A – MK-8150 24 mg (Fed Condition) Panel A – MK-8150 90 mg Panel A – Placebo
Hide Arm/Group Description:
Single dose of MK-8150 2 mg
Single dose of MK-8150 6 mg
Single dose of MK-8150 24 mg
Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
Single dose of MK-8150 90 mg
Single dose of placebo
Overall Number of Participants Analyzed 6 6 6 6 6 8
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
-0.92  (0.61) -2.58  (1.13) -8.01  (1.56) -6.69  (2.30) -9.85  (1.38) -1.24  (0.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 2 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.765
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
-1.82 to 2.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 6 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.34
Confidence Interval (2-Sided) 95%
-2.49 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.56
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg, Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.77
Confidence Interval (2-Sided) 95%
-9.18 to -4.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.17
Estimation Comments Difference is MK-8150 dose – placebo
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Panel A – MK-8150 24 mg (Fed Condition), Panel A – Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010