Trial Outcomes & Findings for A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED) (NCT NCT00758680)
NCT ID: NCT00758680
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 study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
112 participants
Primary outcome timeframe
From Day 1 through the end of poststudy period (up to Day 25)
Results posted on
2016-02-05
Participant Flow
Participant milestones
| Measure |
MK-1006 20 mg Once Daily (Panel A)
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
|
MK-1006 40 mg Once Daily (Panel B)
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 80 mg Once Daily (Panel C)
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily (Panel D)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 20 mg Twice Daily (Panel E)
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 30 mg Twice Daily (Panel F)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 50 mg Twice Daily (Panel G)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily Outpatient (Panel H)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
MK-1006 50 mg Twice Daily Outpatient (Panel I)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
Placebo
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
7
|
20
|
20
|
29
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
19
|
18
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
MK-1006 20 mg Once Daily (Panel A)
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
|
MK-1006 40 mg Once Daily (Panel B)
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 80 mg Once Daily (Panel C)
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily (Panel D)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 20 mg Twice Daily (Panel E)
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 30 mg Twice Daily (Panel F)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 50 mg Twice Daily (Panel G)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily Outpatient (Panel H)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
MK-1006 50 mg Twice Daily Outpatient (Panel I)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
Placebo
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Laboratory Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)
Baseline characteristics by cohort
| Measure |
All Treated Participants
n=112 Participants
After a 2-week run-in/wash-off period, participants received doses of MK-1006 or matching placebo over a multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
|
|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 through the end of poststudy period (up to Day 25)Population: All Participants as Treated (APaT); 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 study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
Outcome measures
| Measure |
MK-1006 20 mg Once Daily (Panel A)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
|
MK-1006 40 mg Once Daily (Panel B)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 80 mg Once Daily (Panel C)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily (Panel D)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 20 mg Twice Daily (Panel E)
n=6 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 30 mg Twice Daily (Panel F)
n=6 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 50 mg Twice Daily (Panel G)
n=7 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily Outpatient (Panel H)
n=20 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
MK-1006 50 mg Twice Daily Outpatient (Panel I)
n=20 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
Placebo
n=29 Participants
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs) On Study
|
1 participants
|
1 participants
|
4 participants
|
5 participants
|
4 participants
|
4 participants
|
6 participants
|
15 participants
|
16 participants
|
22 participants
|
PRIMARY outcome
Timeframe: From Day 1 through the end of poststudy period (up to Day 25)Population: All Participants as Treated (APaT); 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 study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
Outcome measures
| Measure |
MK-1006 20 mg Once Daily (Panel A)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
|
MK-1006 40 mg Once Daily (Panel B)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 80 mg Once Daily (Panel C)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily (Panel D)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 20 mg Twice Daily (Panel E)
n=6 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 30 mg Twice Daily (Panel F)
n=6 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 50 mg Twice Daily (Panel G)
n=7 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily Outpatient (Panel H)
n=20 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
MK-1006 50 mg Twice Daily Outpatient (Panel I)
n=20 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
Placebo
n=29 Participants
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)Population: Per-Protocol Population; subset of participants who complied with the protocol sufficiently in terms of considerations as exposure to treatment, availability of measurements and absence of major protocol violations.
Plasma glucose concentration was determined using a glucometer and measured before drug was given to establish a baseline fasting plasma glucose concentration. Plasma glucose concentrations were then measured every \~30 minutes over a 24 hour period after the Day 1 dose (First Dosing Day) and after the Day 10 dose (Last Dosing Day) to obtain a weighted mean average value for Day 1 and for Day 10. Results were expressed as the change from baseline to the Day 1 weighted average (First Dosing Day), and as the change from baseline to the Day 10 weighted average (Last Dosing Day).
Outcome measures
| Measure |
MK-1006 20 mg Once Daily (Panel A)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
|
MK-1006 40 mg Once Daily (Panel B)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 80 mg Once Daily (Panel C)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily (Panel D)
n=6 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 20 mg Twice Daily (Panel E)
n=6 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 30 mg Twice Daily (Panel F)
n=6 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 50 mg Twice Daily (Panel G)
n=6 Participants
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily Outpatient (Panel H)
n=14 Participants
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
MK-1006 50 mg Twice Daily Outpatient (Panel I)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
Placebo
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)
First Dosing Day
|
-5.3 mg/dL
Standard Deviation 11.3
|
-19.3 mg/dL
Standard Deviation 15.1
|
-43.8 mg/dL
Standard Deviation 10.1
|
-41.5 mg/dL
Standard Deviation 6.3
|
-20.7 mg/dL
Standard Deviation 10.3
|
-26.4 mg/dL
Standard Deviation 20.3
|
-42.5 mg/dL
Standard Deviation 18.6
|
5.3 mg/dL
Standard Deviation 11.1
|
—
|
—
|
|
Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)
Last Dosing Day
|
3.5 mg/dL
Standard Deviation 40.1
|
0.8 mg/dL
Standard Deviation 73.8
|
-66.9 mg/dL
Standard Deviation 20.3
|
-7.4 mg/dL
Standard Deviation 51.4
|
-40.3 mg/dL
Standard Deviation 8.7
|
-30.7 mg/dL
Standard Deviation 30.8
|
-62.1 mg/dL
Standard Deviation 18.8
|
30.2 mg/dL
Standard Deviation 40.6
|
—
|
—
|
Adverse Events
MK-1006 20 mg Once Daily (Panel A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-1006 40 mg Once Daily (Panel B)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-1006 80 mg Once Daily (Panel C)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-1006 120 mg Once Daily (Panel D)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
MK-1006 20 mg Twice Daily (Panel E)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-1006 30 mg Twice Daily (Panel F)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MK-1006 50 mg Twice Daily (Panel G)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MK-1006 120 mg Once Daily Outpatient (Panel H)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
MK-1006 50 mg Twice Daily Outpatient (Panel I)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-1006 20 mg Once Daily (Panel A)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
|
MK-1006 40 mg Once Daily (Panel B)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 80 mg Once Daily (Panel C)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily (Panel D)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 20 mg Twice Daily (Panel E)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 30 mg Twice Daily (Panel F)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 50 mg Twice Daily (Panel G)
n=7 participants at risk
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily Outpatient (Panel H)
n=20 participants at risk
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
MK-1006 50 mg Twice Daily Outpatient (Panel I)
n=20 participants at risk
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
Placebo
n=29 participants at risk
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
3.4%
1/29
|
Other adverse events
| Measure |
MK-1006 20 mg Once Daily (Panel A)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
|
MK-1006 40 mg Once Daily (Panel B)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 80 mg Once Daily (Panel C)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily (Panel D)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 20 mg Twice Daily (Panel E)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 30 mg Twice Daily (Panel F)
n=6 participants at risk
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 50 mg Twice Daily (Panel G)
n=7 participants at risk
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
|
MK-1006 120 mg Once Daily Outpatient (Panel H)
n=20 participants at risk
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
MK-1006 50 mg Twice Daily Outpatient (Panel I)
n=20 participants at risk
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
|
Placebo
n=29 participants at risk
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
57.1%
4/7
|
0.00%
0/20
|
0.00%
0/20
|
3.4%
1/29
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
3.4%
1/29
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
10.3%
3/29
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/20
|
15.0%
3/20
|
0.00%
0/29
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
General disorders
Application Site Irritation
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
3.4%
1/29
|
|
General disorders
Chest Discomfort
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
General disorders
Chest Pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
General disorders
Chills
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
General disorders
Fatigue
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
3.4%
1/29
|
|
General disorders
Malaise
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
General disorders
Oedema Peripheral
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
General disorders
Pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Hepatobiliary disorders
Liver Disorder
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Eye disorders
Asthenopia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Eye disorders
Blepharospasm
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Eye disorders
Diabetic Retinopathy
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Eye disorders
Dry Eye
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Eye disorders
Eye Irritation
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Eye disorders
Eye Pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Eye disorders
Lenticular Opacities
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Eye disorders
Vision Blurred
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
15.0%
3/20
|
0.00%
0/20
|
6.9%
2/29
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Infections and infestations
Viral Infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Investigations
Blood Glucose Decreased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
14.3%
1/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Investigations
Electrocardiogram QT Prolonged
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Investigations
Haematocrit Decreased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
16.7%
1/6
|
16.7%
1/6
|
16.7%
1/6
|
28.6%
2/7
|
25.0%
5/20
|
20.0%
4/20
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
5.0%
1/20
|
5.0%
1/20
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
16.7%
1/6
|
16.7%
1/6
|
0.00%
0/7
|
10.0%
2/20
|
10.0%
2/20
|
13.8%
4/29
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6
|
50.0%
3/6
|
33.3%
2/6
|
0.00%
0/6
|
85.7%
6/7
|
15.0%
3/20
|
25.0%
5/20
|
13.8%
4/29
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
3.4%
1/29
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
10.0%
2/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Nervous system disorders
Tremor
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
15.0%
3/20
|
0.00%
0/29
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
10.0%
2/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
6.9%
2/29
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
10.3%
3/29
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
5.0%
1/20
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/20
|
5.0%
1/20
|
3.4%
1/29
|
|
Vascular disorders
Flushing
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
3.4%
1/29
|
|
Vascular disorders
Hot Flush
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Vascular disorders
Pallor
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
|
Surgical and medical procedures
Peripheral Coldness
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
14.3%
1/7
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/29
|
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