Trial Outcomes & Findings for MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005) (NCT NCT00791661)
NCT ID: NCT00791661
Last Updated: 2016-01-07
Results Overview
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 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 approximately 31 days)
Results posted on
2016-01-07
Participant Flow
Participant milestones
| Measure |
Panel A: MK-1006 15/30/45
Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
|
Panel B: MK-1006 60/80/60 Fed
Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
|
Panel C: MK-1006 100/140/170
Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
|
|---|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
8
|
|
Period 1
Received MK-1006
|
6
|
6
|
6
|
|
Period 1
Received Matching Placebo to MK-1006
|
2
|
2
|
2
|
|
Period 1
COMPLETED
|
8
|
8
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
7 Day Wash-out
STARTED
|
8
|
8
|
6
|
|
7 Day Wash-out
COMPLETED
|
8
|
8
|
6
|
|
7 Day Wash-out
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2
STARTED
|
8
|
8
|
6
|
|
Period 2
Received MK-1006
|
6
|
6
|
4
|
|
Period 2
Received Matching Placebo to MK-1006
|
2
|
2
|
2
|
|
Period 2
COMPLETED
|
8
|
8
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 3
STARTED
|
8
|
8
|
6
|
|
Period 3
Received MK-1006
|
6
|
6
|
5
|
|
Period 3
Received Matching Placebo to MK-1006
|
2
|
2
|
1
|
|
Period 3
COMPLETED
|
8
|
8
|
6
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Panel A: MK-1006 15/30/45
Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
|
Panel B: MK-1006 60/80/60 Fed
Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
|
Panel C: MK-1006 100/140/170
Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
|
|---|---|---|---|
|
7 Day Wash-out
Adverse Event
|
0
|
0
|
1
|
|
7 Day Wash-out
Abnormal Clinical Laboratory Test
|
0
|
0
|
1
|
Baseline Characteristics
MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
Baseline characteristics by cohort
| Measure |
Panel A: MK-1006 15/30/45
n=8 Participants
Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
|
Panel B: MK-1006 60/80/60 Fed
n=8 Participants
Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
|
Panel C: MK-1006 100/140/170
n=8 Participants
Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<41 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
>= 41 years and <=64 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age, Customized
>64 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 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 approximately 31 days)Population: Participants who received study drug. The same participant may appear in more than one treatment arm.
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Outcome measures
| Measure |
MK-1006 15 mg
n=6 Participants
Participants received a single dose of MK-1006 15 mg
|
MK-1006 30 mg
n=6 Participants
Participants received a single dose of MK-1006 30 mg
|
MK-1006 45 mg
n=6 Participants
Participants received a single dose of MK-1006 45 mg
|
MK-1006 60 mg
n=6 Participants
Participants received a single dose of MK-1006 60 mg
|
MK-1006 60 mg Fed
n=6 Participants
Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
|
MK-1006 80 mg
n=6 Participants
Participants received a single dose of MK-1006 80 mg
|
MK-1006 100 mg
n=6 Participants
Participants received a single dose of MK-1006 100 mg
|
MK-1006 140 mg
n=4 Participants
Participants received a single dose of MK-1006 140 mg
|
MK-1006 170 mg
n=5 Participants
Participants received a single dose of MK-1006 170 mg
|
Placebo
n=15 Participants
Participants received matching placebo to MK-1006
|
Placebo Fed
n=2 Participants
Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: up to approximately 17 daysPopulation: Participants who received study drug. The same participant may appear in more than one treatment arm.
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Outcome measures
| Measure |
MK-1006 15 mg
n=6 Participants
Participants received a single dose of MK-1006 15 mg
|
MK-1006 30 mg
n=6 Participants
Participants received a single dose of MK-1006 30 mg
|
MK-1006 45 mg
n=6 Participants
Participants received a single dose of MK-1006 45 mg
|
MK-1006 60 mg
n=6 Participants
Participants received a single dose of MK-1006 60 mg
|
MK-1006 60 mg Fed
n=6 Participants
Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
|
MK-1006 80 mg
n=6 Participants
Participants received a single dose of MK-1006 80 mg
|
MK-1006 100 mg
n=6 Participants
Participants received a single dose of MK-1006 100 mg
|
MK-1006 140 mg
n=4 Participants
Participants received a single dose of MK-1006 140 mg
|
MK-1006 170 mg
n=5 Participants
Participants received a single dose of MK-1006 170 mg
|
Placebo
n=15 Participants
Participants received matching placebo to MK-1006
|
Placebo Fed
n=2 Participants
Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an Adverse Event
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.
Outcome measures
| Measure |
MK-1006 15 mg
n=6 Participants
Participants received a single dose of MK-1006 15 mg
|
MK-1006 30 mg
n=6 Participants
Participants received a single dose of MK-1006 30 mg
|
MK-1006 45 mg
n=6 Participants
Participants received a single dose of MK-1006 45 mg
|
MK-1006 60 mg
n=6 Participants
Participants received a single dose of MK-1006 60 mg
|
MK-1006 60 mg Fed
n=6 Participants
Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
|
MK-1006 80 mg
n=6 Participants
Participants received a single dose of MK-1006 80 mg
|
MK-1006 100 mg
n=6 Participants
Participants received a single dose of MK-1006 100 mg
|
MK-1006 140 mg
n=4 Participants
Participants received a single dose of MK-1006 140 mg
|
MK-1006 170 mg
n=5 Participants
Participants received a single dose of MK-1006 170 mg
|
Placebo
Participants received matching placebo to MK-1006
|
Placebo Fed
Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006
|
489 nM*hr
Standard Deviation 134
|
904 nM*hr
Standard Deviation 249
|
1900 nM*hr
Standard Deviation 384
|
2350 nM*hr
Standard Deviation 897
|
2100 nM*hr
Standard Deviation 556
|
3820 nM*hr
Standard Deviation 1300
|
6060 nM*hr
Standard Deviation 2180
|
6920 nM*hr
Standard Deviation 1420
|
9560 nM*hr
Standard Deviation 3490
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.
Outcome measures
| Measure |
MK-1006 15 mg
n=6 Participants
Participants received a single dose of MK-1006 15 mg
|
MK-1006 30 mg
n=6 Participants
Participants received a single dose of MK-1006 30 mg
|
MK-1006 45 mg
n=6 Participants
Participants received a single dose of MK-1006 45 mg
|
MK-1006 60 mg
n=6 Participants
Participants received a single dose of MK-1006 60 mg
|
MK-1006 60 mg Fed
n=6 Participants
Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
|
MK-1006 80 mg
n=6 Participants
Participants received a single dose of MK-1006 80 mg
|
MK-1006 100 mg
n=6 Participants
Participants received a single dose of MK-1006 100 mg
|
MK-1006 140 mg
n=4 Participants
Participants received a single dose of MK-1006 140 mg
|
MK-1006 170 mg
n=5 Participants
Participants received a single dose of MK-1006 170 mg
|
Placebo
Participants received matching placebo to MK-1006
|
Placebo Fed
Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006
|
358 nM*hr
Standard Deviation 116
|
665 nM*hr
Standard Deviation 186
|
1450 nM*hr
Standard Deviation 315
|
1720 nM*hr
Standard Deviation 782
|
1440 nM*hr
Standard Deviation 342
|
2790 nM*hr
Standard Deviation 1000
|
4610 nM*hr
Standard Deviation 1730
|
5370 nM*hr
Standard Deviation 1330
|
7540 nM*hr
Standard Deviation 3010
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
The placebo group was not evaluated for this outcome measure.
Outcome measures
| Measure |
MK-1006 15 mg
n=6 Participants
Participants received a single dose of MK-1006 15 mg
|
MK-1006 30 mg
n=6 Participants
Participants received a single dose of MK-1006 30 mg
|
MK-1006 45 mg
n=6 Participants
Participants received a single dose of MK-1006 45 mg
|
MK-1006 60 mg
n=6 Participants
Participants received a single dose of MK-1006 60 mg
|
MK-1006 60 mg Fed
n=6 Participants
Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
|
MK-1006 80 mg
n=6 Participants
Participants received a single dose of MK-1006 80 mg
|
MK-1006 100 mg
n=6 Participants
Participants received a single dose of MK-1006 100 mg
|
MK-1006 140 mg
n=4 Participants
Participants received a single dose of MK-1006 140 mg
|
MK-1006 170 mg
n=5 Participants
Participants received a single dose of MK-1006 170 mg
|
Placebo
Participants received matching placebo to MK-1006
|
Placebo Fed
Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006
|
37.3 nM
Standard Deviation 16.3
|
75.4 nM
Standard Deviation 23.9
|
169 nM
Standard Deviation 49.8
|
185 nM
Standard Deviation 102
|
141 nM
Standard Deviation 41
|
310 nM
Standard Deviation 172
|
514 nM
Standard Deviation 180
|
628 nM
Standard Deviation 205
|
912 nM
Standard Deviation 371
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
The placebo group was not evaluated for this outcome measure.
Outcome measures
| Measure |
MK-1006 15 mg
n=6 Participants
Participants received a single dose of MK-1006 15 mg
|
MK-1006 30 mg
n=6 Participants
Participants received a single dose of MK-1006 30 mg
|
MK-1006 45 mg
n=6 Participants
Participants received a single dose of MK-1006 45 mg
|
MK-1006 60 mg
n=6 Participants
Participants received a single dose of MK-1006 60 mg
|
MK-1006 60 mg Fed
n=6 Participants
Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
|
MK-1006 80 mg
n=6 Participants
Participants received a single dose of MK-1006 80 mg
|
MK-1006 100 mg
n=6 Participants
Participants received a single dose of MK-1006 100 mg
|
MK-1006 140 mg
n=4 Participants
Participants received a single dose of MK-1006 140 mg
|
MK-1006 170 mg
n=5 Participants
Participants received a single dose of MK-1006 170 mg
|
Placebo
Participants received matching placebo to MK-1006
|
Placebo Fed
Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006
|
3.0 hours
Interval 2.0 to 5.0
|
4.0 hours
Interval 3.0 to 5.0
|
3.0 hours
Interval 1.0 to 6.0
|
4.0 hours
Interval 1.0 to 5.0
|
5.0 hours
Interval 3.0 to 6.0
|
4.0 hours
Interval 1.0 to 4.0
|
3.5 hours
Interval 1.0 to 6.0
|
5.0 hours
Interval 5.0 to 5.0
|
3.0 hours
Interval 1.0 to 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)Population: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.
Outcome measures
| Measure |
MK-1006 15 mg
n=6 Participants
Participants received a single dose of MK-1006 15 mg
|
MK-1006 30 mg
n=6 Participants
Participants received a single dose of MK-1006 30 mg
|
MK-1006 45 mg
n=6 Participants
Participants received a single dose of MK-1006 45 mg
|
MK-1006 60 mg
n=6 Participants
Participants received a single dose of MK-1006 60 mg
|
MK-1006 60 mg Fed
n=6 Participants
Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
|
MK-1006 80 mg
n=6 Participants
Participants received a single dose of MK-1006 80 mg
|
MK-1006 100 mg
n=6 Participants
Participants received a single dose of MK-1006 100 mg
|
MK-1006 140 mg
n=4 Participants
Participants received a single dose of MK-1006 140 mg
|
MK-1006 170 mg
n=5 Participants
Participants received a single dose of MK-1006 170 mg
|
Placebo
Participants received matching placebo to MK-1006
|
Placebo Fed
Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006
|
18.0 hours
Standard Deviation 5.5
|
18.5 hours
Standard Deviation 3.8
|
19.1 hours
Standard Deviation 2.2
|
18.5 hours
Standard Deviation 3.5
|
17.0 hours
Standard Deviation 1.7
|
21.2 hours
Standard Deviation 2.9
|
22.1 hours
Standard Deviation 5.2
|
20.7 hours
Standard Deviation 2.6
|
21.5 hours
Standard Deviation 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 36 hoursPopulation: Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.
Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.
Outcome measures
| Measure |
MK-1006 15 mg
n=6 Participants
Participants received a single dose of MK-1006 15 mg
|
MK-1006 30 mg
n=6 Participants
Participants received a single dose of MK-1006 30 mg
|
MK-1006 45 mg
n=6 Participants
Participants received a single dose of MK-1006 45 mg
|
MK-1006 60 mg
n=6 Participants
Participants received a single dose of MK-1006 60 mg
|
MK-1006 60 mg Fed
n=6 Participants
Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
|
MK-1006 80 mg
n=6 Participants
Participants received a single dose of MK-1006 80 mg
|
MK-1006 100 mg
n=6 Participants
Participants received a single dose of MK-1006 100 mg
|
MK-1006 140 mg
n=4 Participants
Participants received a single dose of MK-1006 140 mg
|
MK-1006 170 mg
n=5 Participants
Participants received a single dose of MK-1006 170 mg
|
Placebo
n=15 Participants
Participants received matching placebo to MK-1006
|
Placebo Fed
n=2 Participants
Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
24-hour Weighted Mean Glucose (WMG) Concentration
|
206.2 mg/dL
95% Confidence Interval 50.8 • Interval 188.0 to 224.4
|
197.6 mg/dL
95% Confidence Interval 40.9 • Interval 179.1 to 216.1
|
188.6 mg/dL
95% Confidence Interval 28.0 • Interval 170.3 to 206.9
|
178.0 mg/dL
95% Confidence Interval 24.7 • Interval 159.5 to 196.6
|
165.7 mg/dL
95% Confidence Interval 26.7 • Interval 146.8 to 184.6
|
156.7 mg/dL
95% Confidence Interval 21.7 • Interval 138.2 to 175.3
|
199.0 mg/dL
95% Confidence Interval 33.6 • Interval 180.7 to 217.3
|
170.4 mg/dL
95% Confidence Interval 25.8 • Interval 148.9 to 191.9
|
154.9 mg/dL
95% Confidence Interval 21.4 • Interval 134.8 to 175.0
|
214.3 mg/dL
95% Confidence Interval 34.5 • Interval 202.9 to 225.7
|
185.4 mg/dL
95% Confidence Interval 17.7 • Interval 159.5 to 211.3
|
Adverse Events
MK-1006 15 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-1006 30 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-1006 45 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MK-1006 60 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-1006 60 mg Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-1006 80 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MK-1006 100 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-1006 140 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MK-1006 170 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Fed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-1006 15 mg
n=6 participants at risk
Participants received a single dose of MK-1006 15 mg
|
MK-1006 30 mg
n=6 participants at risk
Participants received a single dose of MK-1006 30 mg
|
MK-1006 45 mg
n=6 participants at risk
Participants received a single dose of MK-1006 45 mg
|
MK-1006 60 mg
n=6 participants at risk
Participants received a single dose of MK-1006 60 mg
|
MK-1006 60 mg Fed
n=6 participants at risk
Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
|
MK-1006 80 mg
n=6 participants at risk
Participants received a single dose of MK-1006 80 mg
|
MK-1006 100 mg
n=6 participants at risk
Participants received a single dose of MK-1006 100 mg
|
MK-1006 140 mg
n=4 participants at risk
Participants received a single dose of MK-1006 140 mg
|
MK-1006 170 mg
n=5 participants at risk
Participants received a single dose of MK-1006 170 mg
|
Placebo
n=15 participants at risk
Participants received matching placebo to MK-1006
|
Placebo Fed
n=2 participants at risk
Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/4
The same participant may appear in more than one treatment arm.
|
0.00%
0/5
The same participant may appear in more than one treatment arm.
|
6.7%
1/15
The same participant may appear in more than one treatment arm.
|
0.00%
0/2
The same participant may appear in more than one treatment arm.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/4
The same participant may appear in more than one treatment arm.
|
0.00%
0/5
The same participant may appear in more than one treatment arm.
|
6.7%
1/15
The same participant may appear in more than one treatment arm.
|
0.00%
0/2
The same participant may appear in more than one treatment arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
16.7%
1/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
25.0%
1/4
The same participant may appear in more than one treatment arm.
|
0.00%
0/5
The same participant may appear in more than one treatment arm.
|
0.00%
0/15
The same participant may appear in more than one treatment arm.
|
0.00%
0/2
The same participant may appear in more than one treatment arm.
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/4
The same participant may appear in more than one treatment arm.
|
20.0%
1/5
The same participant may appear in more than one treatment arm.
|
0.00%
0/15
The same participant may appear in more than one treatment arm.
|
0.00%
0/2
The same participant may appear in more than one treatment arm.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
16.7%
1/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/4
The same participant may appear in more than one treatment arm.
|
0.00%
0/5
The same participant may appear in more than one treatment arm.
|
0.00%
0/15
The same participant may appear in more than one treatment arm.
|
0.00%
0/2
The same participant may appear in more than one treatment arm.
|
|
Nervous system disorders
Headache
|
16.7%
1/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
16.7%
1/6
The same participant may appear in more than one treatment arm.
|
16.7%
1/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/4
The same participant may appear in more than one treatment arm.
|
20.0%
1/5
The same participant may appear in more than one treatment arm.
|
0.00%
0/15
The same participant may appear in more than one treatment arm.
|
50.0%
1/2
The same participant may appear in more than one treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
16.7%
1/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
16.7%
1/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/4
The same participant may appear in more than one treatment arm.
|
0.00%
0/5
The same participant may appear in more than one treatment arm.
|
0.00%
0/15
The same participant may appear in more than one treatment arm.
|
0.00%
0/2
The same participant may appear in more than one treatment arm.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
16.7%
1/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/6
The same participant may appear in more than one treatment arm.
|
16.7%
1/6
The same participant may appear in more than one treatment arm.
|
0.00%
0/4
The same participant may appear in more than one treatment arm.
|
0.00%
0/5
The same participant may appear in more than one treatment arm.
|
0.00%
0/15
The same participant may appear in more than one treatment arm.
|
0.00%
0/2
The same participant may appear in more than one treatment arm.
|
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.
- Publication restrictions are in place
Restriction type: OTHER