Trial Outcomes & Findings for MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011). (NCT NCT00754130)
NCT ID: NCT00754130
Last Updated: 2015-03-12
Results Overview
An AE 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. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Up to 14 days after last dose of study drug
Results posted on
2015-03-12
Participant Flow
Participant milestones
| Measure |
Placebo/MK-0941 20mg
Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
|
MK-0941 5mg/Placebo
Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
|
MK-0941 5mg/MK-0941 20mg
Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
|
Placebo/MK-0941 40mg
Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
|
MK-0941 10mg/Placebo
Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
|
MK-0941 10mg/MK-0941 40mg
Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
|
|---|---|---|---|---|---|---|
|
Period 1 (5 Days)
STARTED
|
2
|
2
|
4
|
2
|
2
|
4
|
|
Period 1 (5 Days)
COMPLETED
|
2
|
2
|
4
|
2
|
2
|
4
|
|
Period 1 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period (>=8 Days)
STARTED
|
2
|
2
|
4
|
2
|
2
|
4
|
|
Washout Period (>=8 Days)
COMPLETED
|
2
|
2
|
4
|
2
|
2
|
4
|
|
Washout Period (>=8 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (5 Days)
STARTED
|
2
|
2
|
4
|
2
|
2
|
4
|
|
Period 2 (5 Days)
COMPLETED
|
2
|
2
|
4
|
2
|
2
|
4
|
|
Period 2 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).
Baseline characteristics by cohort
| Measure |
Placebo/MK-0941 20mg
n=2 Participants
Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2
|
MK-0941 5mg/Placebo
n=2 Participants
Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2
|
MK-0941 5mg/MK-0941 20mg
n=4 Participants
Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2
|
Placebo/MK-0941 40mg
n=2 Participants
Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2
|
MK-0941 10mg/Placebo
n=2 Participants
Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2
|
MK-0941 10mg/MK-0941 40mg
n=4 Participants
Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 12.73 • n=99 Participants
|
48.5 years
STANDARD_DEVIATION 2.12 • n=107 Participants
|
45.5 years
STANDARD_DEVIATION 16.58 • n=206 Participants
|
57.0 years
STANDARD_DEVIATION 7.07 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 10.60 • n=31 Participants
|
51.5 years
STANDARD_DEVIATION 11.36 • n=30 Participants
|
50.4 years
STANDARD_DEVIATION 10.82 • n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
14 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after last dose of study drugPopulation: Safety Population, consisting of all randomized participants who received at least one dose of study drug.
An AE 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. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants receiving Placebo doses three times daily
|
MK-0941 5mg
n=6 Participants
Participants receiving MK-0941 5 mg doses three times daily
|
MK-0941 10mg
n=6 Participants
Participants receiving MK-0941 10 mg doses three times daily
|
MK-0941 20mg
n=6 Participants
Participants receiving MK-0941 20 mg doses three times daily
|
MK-0941 40mg
n=5 Participants
Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced at Least One Adverse Event (AE)
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Up to 14 days after last dose of study drugPopulation: Safety Population, consisting of all randomized participants who received at least one dose of study drug.
An AE 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. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants receiving Placebo doses three times daily
|
MK-0941 5mg
n=6 Participants
Participants receiving MK-0941 5 mg doses three times daily
|
MK-0941 10mg
n=6 Participants
Participants receiving MK-0941 10 mg doses three times daily
|
MK-0941 20mg
n=6 Participants
Participants receiving MK-0941 20 mg doses three times daily
|
MK-0941 40mg
n=5 Participants
Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Drug Due to an AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 72 hours after study drug administrationPopulation: Participants with an AUC(0-24hr) measurement
Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants receiving Placebo doses three times daily
|
MK-0941 5mg
n=7 Participants
Participants receiving MK-0941 5 mg doses three times daily
|
MK-0941 10mg
n=5 Participants
Participants receiving MK-0941 10 mg doses three times daily
|
MK-0941 20mg
n=4 Participants
Participants receiving MK-0941 20 mg doses three times daily
|
MK-0941 40mg
Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941
Day 1
|
754 nmol*hr/L
Standard Deviation 165
|
1900 nmol*hr/L
Standard Deviation 885
|
3230 nmol*hr/L
Standard Deviation 654
|
8700 nmol*hr/L
Standard Deviation 2190
|
—
|
|
Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941
Day 5
|
883 nmol*hr/L
Standard Deviation 157
|
2360 nmol*hr/L
Standard Deviation 1260
|
3560 nmol*hr/L
Standard Deviation 863
|
9730 nmol*hr/L
Standard Deviation 3140
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after study drug administrationPopulation: Participants with a Cmax measurement
Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants receiving Placebo doses three times daily
|
MK-0941 5mg
n=7 Participants
Participants receiving MK-0941 5 mg doses three times daily
|
MK-0941 10mg
n=5 Participants
Participants receiving MK-0941 10 mg doses three times daily
|
MK-0941 20mg
n=4 Participants
Participants receiving MK-0941 20 mg doses three times daily
|
MK-0941 40mg
Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941
Day 1
|
105 nmol/L
Standard Deviation 21.5
|
255 nmol/L
Standard Deviation 116
|
487 nmol/L
Standard Deviation 58.3
|
1340 nmol/L
Standard Deviation 269
|
—
|
|
Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941
Day 5
|
128 nmol/L
Standard Deviation 26.2
|
292 nmol/L
Standard Deviation 108
|
509 nmol/L
Standard Deviation 140
|
1240 nmol/L
Standard Deviation 424
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after study drug administrationPopulation: Participants with a Tmax measurement
Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants receiving Placebo doses three times daily
|
MK-0941 5mg
n=7 Participants
Participants receiving MK-0941 5 mg doses three times daily
|
MK-0941 10mg
n=5 Participants
Participants receiving MK-0941 10 mg doses three times daily
|
MK-0941 20mg
n=4 Participants
Participants receiving MK-0941 20 mg doses three times daily
|
MK-0941 40mg
Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941
Day 1
|
3.5 hr
Interval 1.0 to 11.0
|
6.0 hr
Interval 1.0 to 11.0
|
1.0 hr
Interval 1.0 to 6.0
|
1.0 hr
Interval 1.0 to 6.0
|
—
|
|
Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941
Day 5
|
1.0 hr
Interval 1.0 to 11.0
|
1.0 hr
Interval 1.0 to 6.0
|
6.0 hr
Interval 6.0 to 11.0
|
6.0 hr
Interval 6.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after study drug administrationPopulation: Participants with a C24hr measurement
Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants receiving Placebo doses three times daily
|
MK-0941 5mg
n=7 Participants
Participants receiving MK-0941 5 mg doses three times daily
|
MK-0941 10mg
n=5 Participants
Participants receiving MK-0941 10 mg doses three times daily
|
MK-0941 20mg
n=4 Participants
Participants receiving MK-0941 20 mg doses three times daily
|
MK-0941 40mg
Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)
Day 1
|
8.9 nmol/L
Standard Deviation 3.7
|
14.6 nmol/L
Standard Deviation 3.7
|
27.9 nmol/L
Standard Deviation 12.8
|
66.4 nmol/L
Standard Deviation 16.4
|
—
|
|
Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)
Day 5
|
9.5 nmol/L
Standard Deviation 2.1
|
26.0 nmol/L
Standard Deviation 7.4
|
38.5 nmol/L
Standard Deviation 12.5
|
112.8 nmol/L
Standard Deviation 41.4
|
—
|
SECONDARY outcome
Timeframe: Up to 72 hours after study drug administrationPopulation: Participants with a t1/2 measurement
Blood samples for measurement of plasma pharmacokinetic parameters were collected from predose to up to 24 hours postdose on Day 1 and from predose to up to 72 hours postdose on Day 5 in each treatment period.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants receiving Placebo doses three times daily
|
MK-0941 5mg
n=7 Participants
Participants receiving MK-0941 5 mg doses three times daily
|
MK-0941 10mg
n=5 Participants
Participants receiving MK-0941 10 mg doses three times daily
|
MK-0941 20mg
n=4 Participants
Participants receiving MK-0941 20 mg doses three times daily
|
MK-0941 40mg
Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941
Day 5
|
7.7 hr
Standard Deviation 2.0
|
8.3 hr
Standard Deviation 4.1
|
9.9 hr
Standard Deviation 7.2
|
9.1 hr
Standard Deviation 7.3
|
—
|
|
Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941
Day 1
|
5.4 hr
Standard Deviation 1.5
|
4.4 hr
Standard Deviation 1.2
|
4.3 hr
Standard Deviation 1.1
|
3.9 hr
Standard Deviation 1.1
|
—
|
SECONDARY outcome
Timeframe: Day 5 and Day 1Population: All participants with pharmacokinetic measurements on Days 1 and 5
Geometric Mean of the Day 5 to Day 1 Accumulation Ratio
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants receiving Placebo doses three times daily
|
MK-0941 5mg
n=7 Participants
Participants receiving MK-0941 5 mg doses three times daily
|
MK-0941 10mg
n=5 Participants
Participants receiving MK-0941 10 mg doses three times daily
|
MK-0941 20mg
n=4 Participants
Participants receiving MK-0941 20 mg doses three times daily
|
MK-0941 40mg
Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr
AUC(0-24hr) Day 5/Day 1 Accumulation Ratio
|
1.18 Ratio
Interval 1.09 to 1.38
|
1.28 Ratio
Interval 1.09 to 1.42
|
1.09 Ratio
Interval 0.93 to 1.31
|
1.1 Ratio
Interval 1.04 to 1.22
|
—
|
|
Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr
Cmax Day 5/Day 1 Accumulation Ratio
|
1.21 Ratio
Interval 1.05 to 1.42
|
1.18 Ratio
Interval 0.87 to 1.36
|
1.02 Ratio
Interval 0.79 to 1.28
|
0.90 Ratio
Interval 0.72 to 1.08
|
—
|
|
Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr
C24hr Day 5/Day 1 Accumulation Ratio
|
1.1 Ratio
Interval 0.61 to 1.96
|
1.77 Ratio
Interval 1.23 to 2.19
|
1.44 Ratio
Interval 0.81 to 2.01
|
1.65 Ratio
Interval 1.07 to 2.61
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-0941 5mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-0941 10mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-0941 20mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MK-0941 40mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Participants receiving Placebo doses three times daily
|
MK-0941 5mg
n=6 participants at risk
Participants receiving MK-0941 5 mg doses three times daily
|
MK-0941 10mg
n=6 participants at risk
Participants receiving MK-0941 10 mg doses three times daily
|
MK-0941 20mg
n=6 participants at risk
Participants receiving MK-0941 20 mg doses three times daily
|
MK-0941 40mg
n=5 participants at risk
Participants receiving MK-0941 40 mg doses three times daily. One participant randomized to receive MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2 received MK-0941 10 mg during both Periods 1 and 2.
|
|---|---|---|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
12.5%
1/8 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/5 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
|
Eye disorders
Retinopathy
|
12.5%
1/8 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/5 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
16.7%
1/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
16.7%
1/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/5 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
33.3%
2/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/5 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
|
Injury, poisoning and procedural complications
Wound
|
12.5%
1/8 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/5 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/8 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
16.7%
1/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/5 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
16.7%
1/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
16.7%
1/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
20.0%
1/5 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
16.7%
1/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/5 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
20.0%
1/5 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/8 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
16.7%
1/6 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
0.00%
0/5 • Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
This is a crossover-design study; a single participant may be represented in up to two different reporting groups.
|
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