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Trial record 52 of 231 for:    CALCITONIN SALMON

Positron Emission Tomography (PET) Study of Brain Calcitonin Gene-Related Peptide (CGRP) Receptor Occupancy After Telcagepant Administration (MK-0974-067)

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: NCT01315847
Recruitment Status : Completed
First Posted : March 15, 2011
Results First Posted : October 24, 2014
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine
Interventions Drug: telcagepant
Drug: [11C]MK-4232
Enrollment 10
Recruitment Details  
Pre-assignment Details Due to protocol amendment study Part II was not conducted. One subject who started in Part I, Period 2 had not participated in Part I, Period 1. Therefore, the cumulative total number who started Part I (including those starting in Period 1 and 2) is 6. Study participants were included in either Part I or Part III; none were included in both parts.
Arm/Group Title Telcagepant and [11C]MK-4232 (Part I): Healthy Participants Telcagepant and [11C]MK-4232 (Part III): Migraineurs
Hide Arm/Group Description Baseline positron emission tomography (PET) imaging of the brain using [11C]MK-4232 tracer (~300 megabecquerel [MBq]) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
Period Title: Part I, Period 1
Started 5 [1] 0
Received Telcagepant 5 0
Received [11C]MK-4232 5 [2] 0
Completed 2 0
Not Completed 3 0
Reason Not Completed
Reached maximum number of arterial lines             3             0
[1]
Subjects who participated in Part I did not participate in Part III.
[2]
One of these participants received [11C]MK-4232 only at baseline.
Period Title: Part I, Period 2
Started 3 [1] 0
Received Telcagepant 3 0
Received [11C]MK-4232 3 0
Completed 3 0
Not Completed 0 0
[1]
One of these subjects did not participate in Part I, Period 1.
Period Title: Part III, Period 1
Started 0 4 [1]
Received Telcagepant 0 4
Received [11C]MK-4232 0 4 [2]
Completed 0 3
Not Completed 0 1
Reason Not Completed
[11C]MK-4232 synthesis failure             0             1
[1]
Subjects who participated in Part III did not participate in Part I.
[2]
One of these participants received [11C]MK-4232 only at baseline.
Period Title: Part III, Period 2
Started 0 3
Received Telcagepant 0 3
Received [11C]MK-4232 0 3
Completed 0 3
Not Completed 0 0
Arm/Group Title Telcagepant and [11C]MK-4232 (Part I): Healthy Participants Telcagepant and [11C]MK-4232 (Part III): Migraineurs Total
Hide Arm/Group Description Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. Total of all reporting groups
Overall Number of Baseline Participants 6 4 10
Hide Baseline Analysis Population Description
All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 4 participants 10 participants
32.50  (10.63) 37.75  (13.20) 34.60  (11.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
Female
0
   0.0%
4
 100.0%
4
  40.0%
Male
6
 100.0%
0
   0.0%
6
  60.0%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) (Part I)
Hide Description Any AEs occurring among participants (all were healthy subjects) in Part I of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.
Time Frame Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part I of study (Up to approximately 14 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232) in Part I of study.
Arm/Group Title Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
Hide Arm/Group Description:
Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
4
2.Primary Outcome
Title Number of Participants With AEs (Part III)
Hide Description Any AEs occurring among participants (all were migraine patients) in Part III of study were recorded. An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the administration of the study drug, was also an AE.
Time Frame Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 in Part III of study (Up to approximately 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study medication (telcagepant and/or [11C]MK-4232) in Part III of study.
Arm/Group Title Telcagepant and [11C]MK-4232 (Part III): Migraineurs
Hide Arm/Group Description:
In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
4
3.Primary Outcome
Title Brain Calcitonin Gene-related Peptide (CGRP) Receptor Occupancy (RO) Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)
Hide Description Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, regions of interest (ROIs) were drawn throughout cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue time-activity curves (TACs). Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. Total volume of distribution (VT), an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. Change in VT between baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.
Time Frame Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 1 of study, had evaluable data and were compliant with the the study protocol
Arm/Group Title Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
Hide Arm/Group Description:
Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percent CGRP RO
Subject 04 43
Subject 01 48
Subject 103 58
4.Primary Outcome
Title Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Maximum Dose of Telcagepant (1120 mg) in Healthy Participants (Part I, Period 1)
Hide Description In Part I, Period 1 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 2, 3, 4 and 5 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.
Time Frame Part I, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 1 of study, had evaluable data and were compliant with the the study protocol
Arm/Group Title Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
Hide Arm/Group Description:
Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: μM
Subject 04 16.3  (1.84)
Subject 01 20.2  (3.93)
Subject 103 22.2  (4.43)
5.Primary Outcome
Title Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)
Hide Description Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 miniutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.
Time Frame Part I Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part I, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 2 of study, had evaluable data and were compliant with the the study protocol
Arm/Group Title Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
Hide Arm/Group Description:
Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percent CGRP RO
Subject 02 5
Subject 04 10
Subject 101 4
6.Primary Outcome
Title Average Telcagepant Plasma Concentration During PET Imaging Using [11C]MK-4232 Tracer After a Therapeutic Dose of Telcagepant (140 mg) in Healthy Participants (Part I, Period 2)
Hide Description In Part I, Period 2 blood samples for determination of plasma telcagepant concentrations were obtained prior to the telcagepant dose (time 0) and at 1, 2, 3 and 4 hours post telcagepant dose. The average plasma telcagepant concentration during the PET scan was determined, calculated as the area under the plasma telcagepant concentration versus time curve during the PET scanning interval divided by the duration of the PET scanning interval.
Time Frame Part 1, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received both telcagepant and [11C]MK-4232 during Part I, Period 2 of study, had evaluable data and were compliant with the the study protocol
Arm/Group Title Telcagepant and [11C]MK-4232 (Part I): Healthy Participants
Hide Arm/Group Description:
Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: μM
Subject 02 0.254  (0.140)
Subject 04 0.859  (0.305)
Subject 101 0.424  (0.187)
7.Primary Outcome
Title Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Participants With Migraine During a Migraine Attack (Ictal Phase)(Part III, Period 1)
Hide Description Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.
Time Frame Part III, Period 1 Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part III, Period 1 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Results could not be obtained for this measure. For Part III data, the curve fits were unsatisfactory (model curves did not pass through the TAC data points) precluding the quantification of the VT and RO
Arm/Group Title Telcagepant and [11C]MK-4232 (Part III): Migraineurs
Hide Arm/Group Description:
In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Primary Outcome
Title Brain CGRP RO Post Telcagepant Obtained by PET Imaging Using [11C]MK-4232 Tracer at Baseline and After a Therapeutic Dose of Telcagepant (140 mg) in Participants With Migraine During Period When Migraine is Absent (Interictal Phase)(Part III, Period 2)
Hide Description Brain CGRP RO post telcagepant was determined by change in [11C]MK-4232 PET tracer biokinetics at baseline and post telcagepant administration. Using PET brain images acquired over ~0-90 minutes after [11C]MK-4232 dose, ROIs were drawn throughout the cerebral cortex and white matter, striatum, thalamus, cerebellum and pons. The ROIs were projected onto all frames of the dynamic PET scans in order to generate [11C]MK-4232 tissue TACs. Serial arterial blood samples for measurement of plasma radioactivity and [11C]MK-4232 concentrations were collected during the PET scans. These samples provided the arterial input function for a two-tissue compartmental model of [11C]MK-4232 tracer biokinetics. VT, an index of receptor density, was estimated by fitting the two-tissue compartmental model to the PET [11C]MK-4232 TACs. The change in VT between the baseline and post telcagepant PET studies was used to quantify the brain CGRP RO.
Time Frame Part III, Period 2 Baseline, at ~0-90 minutes after [11C]MK-4232 dose; and Part III, Period 2 post telcagepant, at ~0-90 minutes after [11C]MK-4232 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Results could not be obtained for this measure. For Part III data, the curve fits were unsatisfactory (model curves did not pass through the TAC data points) precluding the quantification of the VT and RO
Arm/Group Title Telcagepant and [11C]MK-4232 (Part III): Migraineurs
Hide Arm/Group Description:
In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up 14 days after the last dose of telcagepant and/or [11C]MK-4232 (Up to approximately 14 weeks for Part I, Up to approximately 6 months for Part III)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telcagepant and [11C]MK-4232 (Part I): Healthy Participants Telcagepant and [11C]MK-4232 (Part III): Migraineurs
Hide Arm/Group Description Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
All-Cause Mortality
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants Telcagepant and [11C]MK-4232 (Part III): Migraineurs
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants Telcagepant and [11C]MK-4232 (Part III): Migraineurs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telcagepant and [11C]MK-4232 (Part I): Healthy Participants Telcagepant and [11C]MK-4232 (Part III): Migraineurs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/6 (66.67%)      4/4 (100.00%)    
Cardiac disorders     
Sinus tachycardia  1  0/6 (0.00%)  0 1/4 (25.00%)  1
Eye disorders     
Eye pruritus  1  1/6 (16.67%)  1 0/4 (0.00%)  0
Ocular hyperaemia  1  1/6 (16.67%)  1 0/4 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain upper  1  0/6 (0.00%)  0 1/4 (25.00%)  1
General disorders     
General physical health deterioration  1  1/6 (16.67%)  1 0/4 (0.00%)  0
Infections and infestations     
Cystitis  1  0/6 (0.00%)  0 1/4 (25.00%)  2
Nasopharyngitis  1  0/6 (0.00%)  0 1/4 (25.00%)  1
Investigations     
Blood urine present  1  0/6 (0.00%)  0 1/4 (25.00%)  1
White blood cells urine positive  1  0/6 (0.00%)  0 2/4 (50.00%)  3
Musculoskeletal and connective tissue disorders     
Back pain  1  1/6 (16.67%)  2 0/4 (0.00%)  0
Nervous system disorders     
Headache  1  2/6 (33.33%)  2 2/4 (50.00%)  3
Migraine  1  0/6 (0.00%)  0 4/4 (100.00%)  17
Presyncope  1  0/6 (0.00%)  0 1/4 (25.00%)  1
Psychiatric disorders     
Insomnia  1  1/6 (16.67%)  1 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  1/6 (16.67%)  1 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders     
Ecchymosis  1  0/6 (0.00%)  0 2/4 (50.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01315847     History of Changes
Other Study ID Numbers: 0974-067
First Submitted: February 22, 2011
First Posted: March 15, 2011
Results First Submitted: October 21, 2014
Results First Posted: October 24, 2014
Last Update Posted: April 2, 2019