Trial Outcomes & Findings for A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED) (NCT NCT00757601)
NCT ID: NCT00757601
Last Updated: 2016-02-05
Results Overview
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
Results posted on
2016-02-05
Participant Flow
Participant milestones
| Measure |
60 mg MK1006/80 mg MK1006/100 mg MK1006/Placebo/140 mg MK1006
Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
|
140mg MK1006 / Placebo / 200mg MK1006 / 230mg MK1006 / Placebo
Participants received 140 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5
|
15mg MK1006/Placebo/45mg MK1006/60mg MK1006/Placebo (Fed)
Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5.
|
Placebo/30mg MK1006/45mg MK1006/60mg MK1006/30mg MK1006 (Fed)
Participants received placebo to MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
|
15mg MK1006/30mg MK1006/Placebo/60mg MK1006/30mg MK1006 (Fed)
Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
|
15mg MK1006/30mg MK1006/45mg MK1006/Placebo/30mg MK1006 (Fed)
Participants received 15 mg MK1006 in Period 1, followed by 30 mg MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 30 mg MK1006 taken with food (Fed state) in Period 5.
|
60mg MK1006 / Placebo / 100mg MK1006 / 120mg MK1006 / Placebo
Participants received 60 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by placebo to MK1006 in Period 5.
|
Placebo/80mg MK1006/100mg MK1006/120mg MK1006/140mg MK1006
Participants received placebo to MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by 100 mg MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
|
60mg MK1006/80mg MK1006/Placebo/120mg MK1006/140mg MK1006
Participants received 60 mg MK1006 in Period 1, followed by 80 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 120 mg MK1006 in Period 4, followed by 140 mg MK1006 in Period 5.
|
Placebo/170mg MK1006/200mg MK1006/230mg MK1006/260mg MK1006
Participants received placebo to MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
|
140mg MK1006/170mg MK1006/Placebo/230mg MK1006/260mg MK1006
Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by placebo to MK1006 in Period 3, followed by 230 mg MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
|
140mg MK1006/170mg MK1006/200mg MK1006/Placebo/260mg MK1006
Participants received 140 mg MK1006 in Period 1, followed by 170 mg MK1006 in Period 2, followed by 200 mg MK1006 in Period 3, followed by placebo to MK1006 in Period 4, followed by 260 mg MK1006 in Period 5.
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Period 1
STARTED
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Period 1
COMPLETED
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Period 1
NOT COMPLETED
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Period 2
STARTED
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Period 2
COMPLETED
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Period 2
NOT COMPLETED
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Period 3
STARTED
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Period 3
COMPLETED
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Period 3
NOT COMPLETED
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Period 4
STARTED
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Period 4
COMPLETED
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Period 4
NOT COMPLETED
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Period 5
STARTED
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Period 5
COMPLETED
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Period 5
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
Participants were treated with MK1006 or dose-matched placebo over 5 treatment periods.
|
|---|---|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)Population: All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
Outcome measures
| Measure |
15 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
|
30 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
|
45 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
|
60 mg MK1006
n=12 Participants
After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
|
80 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
|
100 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
|
120 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
|
140 mg MK1006
n=12 Participants
After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
|
170 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
|
200 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
|
230 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
|
260 mg MK1006
n=4 Participants
After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
|
30 mg MK1006 [Fed State]
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
|
Placebo
n=24 Participants
After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Number of Participants Experiencing Adverse Events (AEs) On Study
|
2 participants
|
3 participants
|
3 participants
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2 participants
|
2 participants
|
1 participants
|
1 participants
|
5 participants
|
1 participants
|
3 participants
|
2 participants
|
3 participants
|
2 participants
|
13 participants
|
PRIMARY outcome
Timeframe: From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)Population: All Participants as Treated (APaT) Population; All participants who received at least one dose of the investigational drug.
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the treatment, was also considered an adverse experience.
Outcome measures
| Measure |
15 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
|
30 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
|
45 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
|
60 mg MK1006
n=12 Participants
After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
|
80 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
|
100 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
|
120 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
|
140 mg MK1006
n=12 Participants
After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
|
170 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
|
200 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
|
230 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
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260 mg MK1006
n=4 Participants
After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
|
30 mg MK1006 [Fed State]
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
|
Placebo
n=24 Participants
After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Number of Participants Who Discontinued Treatment Due to an AE
|
0 participants
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0 participants
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0 participants
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0 participants
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0 participants
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0 participants
|
0 participants
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0 participants
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0 participants
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0 participants
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0 participants
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0 participants
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0 participants
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0 participants
|
SECONDARY outcome
Timeframe: From pre-dose to 168 hours post-dosePopulation: Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.
The AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Outcome measures
| Measure |
15 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
|
30 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
|
45 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
|
60 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
|
80 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
|
100 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
|
120 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
|
140 mg MK1006
n=7 Participants
After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
|
170 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
|
200 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
|
230 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
|
260 mg MK1006
n=4 Participants
After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
|
30 mg MK1006 [Fed State]
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
|
Placebo
After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-∞]) After Single Dose MK1006
|
595 nM.hr
Standard Deviation 106
|
1330 nM.hr
Standard Deviation 193
|
1900 nM.hr
Standard Deviation 464
|
2790 nM.hr
Standard Deviation 810
|
4380 nM.hr
Standard Deviation 1960
|
6360 nM.hr
Standard Deviation 2680
|
7670 nM.hr
Standard Deviation 1900
|
7500 nM.hr
Standard Deviation 2800
|
8160 nM.hr
Standard Deviation 3570
|
8440 nM.hr
Standard Deviation 5520
|
11670 nM.hr
Standard Deviation 4020
|
11460 nM.hr
Standard Deviation 5340
|
1380 nM.hr
Standard Deviation 271
|
—
|
SECONDARY outcome
Timeframe: From pre-dose to 168 hours post-dosePopulation: Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.
Outcome measures
| Measure |
15 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
|
30 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
|
45 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
|
60 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
|
80 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
|
100 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
|
120 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
|
140 mg MK1006
n=7 Participants
After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
|
170 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
|
200 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
|
230 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
|
260 mg MK1006
n=4 Participants
After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
|
30 mg MK1006 [Fed State]
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
|
Placebo
After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Maximum Plasma Concentration (Cmax) of MK1006 After Single Dose
|
60.0 nM
Standard Deviation 22.7
|
123.0 nM
Standard Deviation 27.7
|
191.0 nM
Standard Deviation 76.5
|
251.0 nM
Standard Deviation 73.4
|
434.0 nM
Standard Deviation 196.0
|
614.0 nM
Standard Deviation 267.0
|
783.0 nM
Standard Deviation 230.0
|
786.0 nM
Standard Deviation 422.
|
768.0 nM
Standard Deviation 364.0
|
738.0 nM
Standard Deviation 688.0
|
1174.0 nM
Standard Deviation 822.0
|
901.0 nM
Standard Deviation 508.0
|
141.0 nM
Standard Deviation 37.4
|
—
|
SECONDARY outcome
Timeframe: From pre-dose to 168 hours post-dosePopulation: Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.
Outcome measures
| Measure |
15 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
|
30 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
|
45 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
|
60 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
|
80 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
|
100 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
|
120 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
|
140 mg MK1006
n=7 Participants
After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
|
170 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
|
200 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
|
230 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
|
260 mg MK1006
n=4 Participants
After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
|
30 mg MK1006 [Fed State]
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
|
Placebo
After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Time of Maximum Plasma Concentration (Tmax) of MK1006 After Single Dose
|
1.5 hr
Interval 1.0 to 6.0
|
2.0 hr
Interval 1.0 to 5.0
|
3.0 hr
Interval 2.0 to 5.0
|
3.0 hr
Interval 3.0 to 5.0
|
3.0 hr
Interval 2.0 to 5.0
|
3.0 hr
Interval 2.0 to 5.0
|
4.0 hr
Interval 1.0 to 5.0
|
3.0 hr
Interval 2.0 to 5.0
|
3.5 hr
Interval 1.0 to 5.0
|
5.0 hr
Interval 2.0 to 5.0
|
4.0 hr
Interval 2.0 to 5.0
|
4.5 hr
Interval 4.0 to 5.0
|
2.0 hr
Interval 2.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: From pre-dose to 168 hours post-dosePopulation: Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.
The apparent terminal half-life was defined as the time required for the plasma concentration of MK1006 to decrease 50% in the final stage of its elimination
Outcome measures
| Measure |
15 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
|
30 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
|
45 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
|
60 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
|
80 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
|
100 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
|
120 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
|
140 mg MK1006
n=7 Participants
After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
|
170 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
|
200 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
|
230 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
|
260 mg MK1006
n=4 Participants
After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
|
30 mg MK1006 [Fed State]
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
|
Placebo
After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-Life (T 1/2) of MK1006 After Single Dose
|
17.0 hr
Standard Deviation 3.1
|
17.3 hr
Standard Deviation 1.3
|
17.6 hr
Standard Deviation 3.5
|
18.3 hr
Standard Deviation 2.3
|
20.0 hr
Standard Deviation 1.4
|
23.0 hr
Standard Deviation 5.2
|
19.3 hr
Standard Deviation 4.7
|
25.7 hr
Standard Deviation 5.6
|
22.3 hr
Standard Deviation 5.6
|
22.8 hr
Standard Deviation 5.0
|
26.7 hr
Standard Deviation 2.6
|
31.3 hr
Standard Deviation 6.6
|
19.2 hr
Standard Deviation 3.2
|
—
|
SECONDARY outcome
Timeframe: From pre-dose to 168 hours post-dosePopulation: Per-Protocol (PP) Population; The subset of participants who complied with the protocol sufficiently to ensure that data was likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements and absence of major protocol violations.
The AUC(0-24) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose.
Outcome measures
| Measure |
15 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
|
30 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
|
45 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
|
60 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
|
80 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
|
100 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
|
120 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
|
140 mg MK1006
n=7 Participants
After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
|
170 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
|
200 mg MK1006
n=5 Participants
After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
|
230 mg MK1006
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
|
260 mg MK1006
n=4 Participants
After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
|
30 mg MK1006 [Fed State]
n=6 Participants
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
|
Placebo
After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Area Under The Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose MK1006
|
468 nM.hr
Standard Deviation 101
|
1030 nM.hr
Standard Deviation 155
|
1520 nM.hr
Standard Deviation 416
|
2100 nM.hr
Standard Deviation 580
|
3450 nM.hr
Standard Deviation 1570
|
4930 nM.hr
Standard Deviation 2120
|
6110 nM.hr
Standard Deviation 1420
|
5690 nM.hr
Standard Deviation 2490
|
6590 nM.hr
Standard Deviation 3320
|
6270 nM.hr
Standard Deviation 4850
|
8810 nM.hr
Standard Deviation 3780
|
8500 nM.hr
Standard Deviation 4380
|
1060 nM.hr
Standard Deviation 232
|
—
|
Adverse Events
15 mg MK1006
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
30 mg MK1006
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
45 mg MK1006
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
60 mg MK1006
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
80 mg MK1006
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
100 mg MK1006
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
120 mg MK1006
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
140 mg MK1006
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
170 mg MK1006
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
200 mg MK1006
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
230 mg MK1006
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
260 mg MK1006
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
30 mg MK1006 [Fed State]
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
15 mg MK1006
n=6 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 15 mg MK1006 after an overnight fast.
|
30 mg MK1006
n=6 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after an overnight fast
|
45 mg MK1006
n=6 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 45 mg MK1006 after an overnight fast.
|
60 mg MK1006
n=12 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 60 mg MK1006 after an overnight fast.
|
80 mg MK1006
n=6 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 80 mg MK1006 after an overnight fast.
|
100 mg MK1006
n=6 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 100 mg MK1006 after an overnight fast.
|
120 mg MK1006
n=6 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 120 mg MK1006 after an overnight fast.
|
140 mg MK1006
n=12 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 140 mg MK1006 after an overnight fast.
|
170 mg MK1006
n=6 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 170 mg MK1006 after an overnight fast.
|
200 mg MK1006
n=6 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 200 mg MK1006 after an overnight fast.
|
230 mg MK1006
n=6 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 230 mg MK1006 after an overnight fast.
|
260 mg MK1006
n=4 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 260 mg MK1006 after an overnight fast.
|
30 mg MK1006 [Fed State]
n=6 participants at risk
After a minimum washout period of 7 days, participants received a single dose of 30 mg MK1006 after a light breakfast.
|
Placebo
n=24 participants at risk
After a minimum washout period of 7 days, participants received a single dose of dose-matched placebo to MK1006.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Eye disorders
Dry Eye
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
33.3%
2/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
4.2%
1/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
4.2%
1/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Eye disorders
Pterygium
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Eye disorders
Vision Blurred
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
2/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
4.2%
1/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
2/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
4.2%
1/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
General disorders
Asthenia
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
General disorders
Chills
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
General disorders
Feeling Hot
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
General disorders
Infusion Site Pain
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Infections and infestations
Otitis Externa
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
4.2%
1/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
25.0%
1/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
4.2%
1/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Investigations
Electrocardiogram T Wave Abnormal
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
2/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
2/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
2/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
25.0%
1/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
25.0%
1/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
4.2%
1/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
2/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
33.3%
2/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
33.3%
2/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
2/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
33.3%
2/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
4/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
4.2%
1/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Skin and subcutaneous tissue disorders
Ingrown Hair
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
4.2%
1/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
16.7%
1/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
8.3%
1/12 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/4 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/6 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
0.00%
0/24 • From the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to 3 weeks)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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 guidelines.
- Publication restrictions are in place
Restriction type: OTHER