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Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia

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: NCT01898884
Recruitment Status : Completed
First Posted : July 15, 2013
Results First Posted : October 6, 2016
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Friedreich's Ataxia
Interventions Drug: VP 20629
Drug: Placebo
Enrollment 46
Recruitment Details This is a multicenter study conducted between 13 August 2013 and 18 June 2015.
Pre-assignment Details A total of 46 participants were enrolled to the study, of which 32 were randomly assigned to single-dose group and 24 were randomly assigned to multiple-dose group. Participants who received investigational product in a single-dose group and completed the post-treatment safety assessment were allowed to enrol in a multiple-dose group.
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1. Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1. Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1. Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1. Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1. Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions. Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions. Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions. Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Period Title: Single Dose Period
Started 8 6 6 6 6 0 0 0 0
Completed 8 6 6 6 6 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Multiple Dose Period
Started 0 0 0 0 0 6 [1] 6 [1] 6 [1] 6 [1]
Treated 0 0 0 0 0 6 6 6 5
Completed 0 0 0 0 0 6 5 6 5
Not Completed 0 0 0 0 0 0 1 0 1
Reason Not Completed
Adverse Event             0             0             0             0             0             0             1             0             0
Randomized Not Treated             0             0             0             0             0             0             0             0             1
[1]
Eligible participants who completed single dose treatment were randomized to multiple dose groups.
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg Total
Hide Arm/Group Description Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1. Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1. Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1. Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1. Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 8 6 6 6 6 32
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) set consisted of all participants who were randomly assigned to an investigational product treatment group. The baseline data for 14 participants who were randomised directly to multiple dose groups, was not summarised and not reported.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants 32 participants
25.1  (7.04) 22.7  (1.97) 27.8  (4.45) 28.0  (6.90) 26.8  (8.86) 26.0  (6.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 6 participants 6 participants 6 participants 32 participants
Female
5
  62.5%
3
  50.0%
2
  33.3%
3
  50.0%
4
  66.7%
17
  53.1%
Male
3
  37.5%
3
  50.0%
4
  66.7%
3
  50.0%
2
  33.3%
15
  46.9%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs), defined as all AEs that start during study drug treatment (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during study drug treatment (and up to 7 days after the last dose of study drug).
Time Frame From Start of Study Treatment up to Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT-safety (ITT-S) set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 8 6 6 6 6 6 6 6 5
Measure Type: Number
Unit of Measure: participants
TEAE 3 0 4 5 6 4 3 6 3
TESAE 0 0 0 0 0 0 1 0 0
2.Primary Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hide Description An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 7 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with Grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.
Time Frame From Start of Study Treatment up to Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 8 6 6 6 6 6 6 6 5
Measure Type: Number
Unit of Measure: participants
Blood Glucose Increased 0 0 0 0 1 0 0 0 0
Neutrophil Count Decreased 0 0 0 0 0 0 0 1 0
3.Primary Outcome
Title Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hide Description Vital sign assessments included systolic blood pressure, diastolic blood pressure, heart rate, and temperature. Vital signs abnormalities reported as TEAEs were reported.
Time Frame From Start of Study Treatment up to Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 8 6 6 6 6 6 6 6 5
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0 0 0 0 0
4.Primary Outcome
Title Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)
Hide Description ECG included PR interval, QRS interval, QTcB interval, QTcF interval were considered as clinically significant ECG abnormalities.
Time Frame From Start of Study Treatment up to Day 19
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 8 6 6 6 6 6 6 6 5
Measure Type: Number
Unit of Measure: participants
0 1 0 0 0 0 1 0 0
5.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups
Hide Description The Cmax is the maximum observed plasma concentration of single dose of VP 20629 and VP 20631.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" (Number of participants analyzed) and "n" are number of participants analyzed for this outcome measure and for the specified compound, respectively.
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 7 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
VP 20629 (n=7,6,6,6,6) 269  (92) 29350  (6344) 47350  (12742) 76983  (7293) 73717  (14848)
VP 20631 (n=6,6,6,6,6) 7  (2) 1068  (353) 3556  (2347) 12515  (6056) 15842  (12438)
6.Secondary Outcome
Title Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups
Hide Description The Tmax is the time to reach maximum observed plasma concentration of single dose of VP 20629 and VP 20631.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" (Number of participants analyzed) and "n" are number of participants analyzed for this outcome measure and for the specified compound, respectively.
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 7 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hour
VP 20629 (n=7,6,6,6,6) 9.94  (7.58) 1.50  (0.45) 1.92  (0.95) 1.83  (0.61) 3.01  (1.77)
VP 20631(n=6,6,6,6,6) 23.71  (20.17) 2.17  (0.41) 2.83  (2.50) 2.16  (0.60) 3.35  (2.33)
7.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups
Hide Description The AUC is the area under the plasma concentration-time curve observed.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.
Arm/Group Title Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
VP 20629 152277  (27113) 298443  (42925) 463893  (44896) 525976  (107856)
VP 20631 5118  (1155) 14208  (4117) 33366  (9374) 48322  (17989)
8.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups
Hide Description The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" (Number of participants analyzed) and "n" are number of participants analyzed for this outcome measure and for the specified compound, respectively.
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 7 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
VP 20629 (n=7,6,6,6,6) 1708  (693) 95673  (10720) 183398  (10155) 302823  (31529) 325019  (45937)
VP 20631 (n=5,6,6,6,6) 21  (27) 3201  (802) 9934  (4155) 27426  (8969) 37258  (19280)
9.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve to the Last Measurable Plasma Concentration (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups
Hide Description The AUCt is the measure of the plasma drug concentration from time zero to time t.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" (Number of participants analyzed) and "n" are number of participants analyzed for this outcome measure and for the specified compound, respectively.
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 7 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
VP 20629 (n=7,6,6,6,6) 9903  (4192) 147287  (25078) 294510  (41445) 457563  (46848) 519996  (106355)
VP 20631 (n=6,6,6,6,6) 164  (149) 4876  (1201) 14070  (4110) 33121  (9322) 48114  (17934)
10.Secondary Outcome
Title Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups
Hide Description The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.
Arm/Group Title Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Median (Full Range)
Unit of Measure: hour
VP 20629
9.98
(8.46 to 13.56)
7.87
(7.62 to 8.46)
7.43
(4.40 to 9.44)
7.85
(6.62 to 8.97)
VP 20631
11.19
(9.14 to 15.09)
7.85
(7.13 to 8.22)
7.72
(4.52 to 9.46)
6.95
(6.29 to 8.52)
11.Secondary Outcome
Title Volume of Distribution (Vz/F) of VP 20629 for Single Dose Groups
Hide Description The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.
Arm/Group Title Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: Liter
15.0  (3.4) 17.6  (2.9) 20.8  (6.1) 26.9  (6.3)
12.Secondary Outcome
Title Total Body Drug Clearance (CL/F) of VP 20629 for Single Dose Groups
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.
Arm/Group Title Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: liter per hour
1.010  (0.171) 1.533  (0.209) 1.956  (0.196) 2.357  (0.447)
13.Secondary Outcome
Title Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups
Hide Description Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.
Arm/Group Title Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: per hour
VP 20629 0.0688  (0.0111) 0.0874  (0.0033) 0.1007  (0.0312) 0.0892  (0.0105)
VP 20631 0.0615  (0.0114) 0.0889  (0.0046) 0.0958  (0.0295) 0.0972  (0.0124)
14.Secondary Outcome
Title Cumulative Amount Excreted Into the Urine (Ae) for Unchanged VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups
Hide Description The Ae is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.
Time Frame 0-4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 4 4 5 5
Mean (Standard Deviation)
Unit of Measure: microgram (mcg)
VP 20629 55.0  (17.2) 79.4  (13.3) 368.6  (196.3) 518.1  (105.6)
VP 20631 131644.9  (19834.5) 529022.1  (92223.8) 953370.1  (116994.6) 1263419.7  (190242.9)
15.Secondary Outcome
Title Percentage of Drug Excreted in Urine (Ae%) of VP 20629 for Single Dose Groups
Hide Description The Ae% is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.
Time Frame -4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 4 4 5 5
Mean (Standard Deviation)
Unit of Measure: percentage of dose
0.0367  (0.0115) 0.0176  (0.0030) 0.0410  (0.0218) 0.0432  (0.0088)
16.Secondary Outcome
Title Renal Clearance (CLR) of VP 20629 for Single Dose Groups
Hide Description The CLR is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 1 or Ae(0-24)/AUC(0-24) on Day 1.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Single Dose VP 20629 150 mg Single Dose VP 20629 450 mg Single Dose VP 20629 900 mg Single Dose VP 20629 1200 mg
Hide Arm/Group Description:
Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
Overall Number of Participants Analyzed 4 4 5 5
Mean (Standard Deviation)
Unit of Measure: liter per hour
0.0003  (0.0001) 0.0003  (0.0001) 0.0008  (0.0005) 0.0010  (0.0002)
17.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description The Cmax is the maximum observed plasma concentration of Multiple Dose of VP 20629 and VP 20631.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" (Number of participants analyzed) and "n" are number of participants analyzed for this outcome measure and for the specified compound, respectively.
Arm/Group Title Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 6 6 6 5
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
VP 20629 (n=6,6,6,5) 172  (82) 21667  (2890) 30000  (5592) 40440  (8878)
VP 20631 (n=1,6,6,5) 6 [1]   (NA) 556  (88) 1270  (446) 2094  (480)
[1]
Standard deviation was not evaluable as only 1 participant was analyzed.
18.Secondary Outcome
Title Maximum Observed Serum Concentration at Steady State (Cmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description The Cmax,ss is the maximum observed plasma concentration at steady state.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" (Number of participants analyzed) and "n" are number of participants analyzed for this outcome measure and for the specified compound, respectively.
Arm/Group Title Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 6 6 6 5
Mean (Standard Deviation)
Unit of Measure: ng/mL
VP 20629 (n=6,5,6,5) 212  (54) 25060  (10656) 32583  (6941) 45000  (3431)
VP 20631 (n=4,5,6,5) 5  (3) 754  (194) 1638  (252) 3156  (1305)
19.Secondary Outcome
Title Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description The Tmax is the time to reach maximum observed plasma concentration of multiple dose of VP 20629 and VP 20631.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" (Number of participants analyzed) and "n" are number of participants analyzed for this outcome measure and for the specified compound, respectively.
Arm/Group Title Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 6 6 6 5
Mean (Standard Deviation)
Unit of Measure: hour
VP 20629 (n=6,6,6,5) 3.24  (1.72) 1.09  (0.38) 1.42  (0.38) 1.63  (0.71)
VP 20631 (n=1,6,6,5) 0.58 [1]   (NA) 1.42  (0.49) 1.59  (0.38) 2.02  (0.82)
[1]
Standard deviation was not evaluable as only 1 participant was analyzed.
20.Secondary Outcome
Title Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description The Tmax,ss is the time to reach maximum observed plasma concentration at steady state of multiple dose of VP 20629 and VP 20631.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" (Number of participants analyzed) and "n" are number of participants analyzed for this outcome measure and for the specified compound, respectively.
Arm/Group Title Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 6 5 6 5
Mean (Standard Deviation)
Unit of Measure: hour
VP 20629 (n=6,5,6,5) 6.65  (3.96) 0.97  (0.04) 2.00  (0.32) 1.80  (0.91)
VP 20631 (n=4,5,6,5) 0.50  (0.71) 1.67  (0.42) 2.26  (0.53) 1.90  (0.89)
21.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description The AUC is the area under the plasma concentration-time curve observed.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 5 6 5
Mean (Standard Deviation)
Unit of Measure: h*ng/ml
VP 20629 184407  (108180) 217115  (58417) 332140  (73876)
VP 20631 5156  (1869) 9299  (2402) 14807  (2206)
22.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description The AUCss is the area under the plasma concentration time curve observed during a dosing at steady state.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 5 6 5
Mean (Standard Deviation)
Unit of Measure: h*ng/ml
VP 20629 99794  (44105) 138567  (37102) 196587  (18647)
VP 20631 2848  (677) 6006  (1215) 9732  (1932)
23.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6 and 8 hours Postdose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "n" is number of participants analyzed for this outcome measure at given time points.
Arm/Group Title Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 6 6 6 5
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
VP 20629 (n=6,6,6,5) 1080  (451) 72054  (21395) 113510  (26091) 144059  (10302)
VP 20631 (n=1,6,6,5) 20 [1]   (NA) 1926  (315) 4130  (1137) 5740  (1076)
[1]
Standard deviation was not evaluable as only 1 participant was analyzed.
24.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description The AUCtau is the measure of the plasma drug concentration from time zero to time t.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" (Number of participants analyzed) and "n" are number of participants analyzed for this outcome measure and for the specified compound, respectively.
Arm/Group Title Multiple Dose Placebo Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 6 5 6 5
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
VP 20629 (n=6,5,6,5) 6769  (1480) 177487  (102429) 212568  (57087) 325464  (72038)
VP 20631 (n=4,5,6,5) 81  (124) 4992  (1790) 9103  (2358) 14570  (2177)
25.Secondary Outcome
Title Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 5 6 5
Mean (Standard Deviation)
Unit of Measure: hour
VP 20629 9.95  (1.09) 9.07  (1.21) 9.05  (1.18)
VP 20631 10.01  (0.44) 9.68  (1.45) 9.11  (0.96)
26.Secondary Outcome
Title Volume of Distribution (Vz/F) of VP 20629 for Multiple Dose Groups
Hide Description The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 5 6 5
Mean (Standard Deviation)
Unit of Measure: liter
16.05  (5.28) 19.77  (4.62) 20.03  (2.98)
27.Secondary Outcome
Title Total Body Drug Clearance at Steady State (CLss/F) of VP 20629 for Multiple Dose Groups
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 5 6 5
Mean (Standard Deviation)
Unit of Measure: liter per hour
1.133  (0.388) 1.524  (0.364) 1.537  (0.140)
28.Secondary Outcome
Title Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 5 6 5
Mean (Standard Deviation)
Unit of Measure: per hour
VP 20629 0.0703  (0.0076) 0.0775  (0.0094) 0.0777  (0.0111)
VP 20631 0.0693  (0.0031) 0.0729  (0.0107) 0.0768  (0.0085)
29.Secondary Outcome
Title Cumulative Amount Excreted Into the Urine at Steady State (Ae,ss) of Unchanged VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups
Hide Description The Ae,ss is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.
Time Frame 0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 5 4 4
Mean (Standard Deviation)
Unit of Measure: microgram
VP 20629 56.8  (48.1) 111.4  (27.5) 244.3  (226.6)
VP 20631 110042  (10852) 254540  (52440) 283873  (78764)
30.Secondary Outcome
Title Percentage of Drug Excreted in Urine at Steady-State (Ae%,ss) of VP 20629 for Multiple Dose Groups
Hide Description The Ae%,ss is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.
Time Frame 0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 5 4 4
Mean (Standard Deviation)
Unit of Measure: percentage of dose
0.0568  (0.0481) 0.0557  (0.0138) 0.0814  (0.0755)
31.Secondary Outcome
Title Renal Clearance at Steady State (CLR,ss) of VP 20629 for Multiple Dose Groups
Hide Description The CLR,ss is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 8.
Time Frame Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.
Arm/Group Title Multiple Dose VP 20629 300 mg Multiple Dose VP 20629 600 mg Multiple Dose VP 20629 900 mg
Hide Arm/Group Description:
Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Overall Number of Participants Analyzed 5 4 4
Mean (Standard Deviation)
Unit of Measure: liter per hour
0.0005  (0.0002) 0.0009  (0.0004) 0.0013  (0.0013)
Time Frame From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Dose Placebo Single Dose VP 20629 150mg Single Dose VP 20629 450mg Single Dose VP 20629 900mg Single Dose VP 20629 1200mg Multiple Dose Placebo Multiple Dose VP 20629 300mg Multiple Dose VP 20629 600mg Multiple Dose VP 20629 900mg
Hide Arm/Group Description Participants received placebo matching to single dose of VP 20629 capsules orally under fasting conditions on Day 1. Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting conditions on Day 1. Participants received single dose VP 20629 capsules of 450 mg orally under fasting conditions on Day 1. Participants received single dose VP 20629 capsules of 900 mg orally under fasting conditions on Day 1. Participants received single dose VP 20629 capsules of 1200 mg orally under fasting conditions on Day 1. Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions. Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions. Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions. Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
All-Cause Mortality
Single Dose Placebo Single Dose VP 20629 150mg Single Dose VP 20629 450mg Single Dose VP 20629 900mg Single Dose VP 20629 1200mg Multiple Dose Placebo Multiple Dose VP 20629 300mg Multiple Dose VP 20629 600mg Multiple Dose VP 20629 900mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single Dose Placebo Single Dose VP 20629 150mg Single Dose VP 20629 450mg Single Dose VP 20629 900mg Single Dose VP 20629 1200mg Multiple Dose Placebo Multiple Dose VP 20629 300mg Multiple Dose VP 20629 600mg Multiple Dose VP 20629 900mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      1/6 (16.67%)      0/6 (0.00%)      0/5 (0.00%)    
Cardiac disorders                   
Angina pectoris * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Dose Placebo Single Dose VP 20629 150mg Single Dose VP 20629 450mg Single Dose VP 20629 900mg Single Dose VP 20629 1200mg Multiple Dose Placebo Multiple Dose VP 20629 300mg Multiple Dose VP 20629 600mg Multiple Dose VP 20629 900mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/8 (37.50%)      0/6 (0.00%)      4/6 (66.67%)      5/6 (83.33%)      6/6 (100.00%)      4/6 (66.67%)      3/6 (50.00%)      6/6 (100.00%)      3/5 (60.00%)    
Cardiac disorders                   
Angina pectoris * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Cardiac discomfort * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Palpitations * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Eye disorders                   
Vision blurred * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Gastrointestinal disorders                   
Abdominal distension * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Abdominal pain * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Diarrhoea * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Dry mouth * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Flatulence * 1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1 0/5 (0.00%)  0
Nausea * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Vomiting * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
General disorders                   
Chest pain * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Fatigue * 1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Infusion site pain * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Local swelling * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Pyrexia * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Infections and infestations                   
Cellulitis * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Skin infection * 1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Injury, poisoning and procedural complications                   
Foot fracture * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Laceration * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Sunburn * 1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Investigations                   
Blood glucose increased * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Electrocardiogram qt prolonged * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Neutrophil count decreased * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Back pain * 1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/5 (0.00%)  0
Musculoskeletal pain * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Musculoskeletal stiffness * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Nervous system disorders                   
Balance disorder * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Dizziness * 1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  3 1/5 (20.00%)  1
Headache * 1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 3/6 (50.00%)  3 0/6 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1 1/6 (16.67%)  2 0/5 (0.00%)  0
Motor dysfunction * 1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Somnolence * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Psychiatric disorders                   
Insomnia * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Nightmare * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Renal and urinary disorders                   
Urinary incontinence * 1  1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Dyspnoea * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Nasal congestion * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Alopecia * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Blister * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Hyperhidrosis * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  2 0/5 (0.00%)  0
Pruritus * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Rash * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Rash papular * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
Skin irritation * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Vascular disorders                   
Hypertension * 1  0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution may publish results generated from the site individually.
Results Point of Contact
Name/Title: Study Physician
Organization: Shire
Phone: 1 866-842-5335
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01898884     History of Changes
Other Study ID Numbers: 20629-100
First Submitted: July 3, 2013
First Posted: July 15, 2013
Results First Submitted: June 16, 2016
Results First Posted: October 6, 2016
Last Update Posted: December 5, 2018