Trial Outcomes & Findings for Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008) (NCT NCT01244035)
NCT ID: NCT01244035
Last Updated: 2019-02-28
Results Overview
The number of participants with one or more clinical or laboratory AEs was assessed. 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 SPONSOR's product, whether or not considered related to the use of the product.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE was reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
Results posted on
2019-02-28
Participant Flow
The same participants in Part 1 were to continue in Part 2, pending the planned evaluation of Part 1 pharmacodynamic results. Based on the Part 1 results, no participants continued to Part 2.
Participant milestones
| Measure |
Sequence ABC
MK-8266 1.3 mg BID, then MK-8266 0.9 mg FDD, then Placebo
|
Sequence ACB
MK-8266 1.3 mg BID, then Placebo, then MK-8266 0.9 mg FDD
|
Sequence BCA
MK-8266 0.9 mg FDD, then Placebo, then MK-8266 1.3 mg BID
|
Sequence BAC
MK-8266 0.9 mg FDD, then MK-8266 1.3 mg BID, then Placebo
|
Sequence CAB
Placebo, then MK-8266 1.3 mg BID, then MK-8266 0.9 mg FDD
|
Sequence CBA
Placebo, then MK-8266 0.9 mg FDD, then MK-8266 1.3 mg BID
|
|---|---|---|---|---|---|---|
|
Part 1: Period 1
STARTED
|
5
|
5
|
6
|
5
|
5
|
5
|
|
Part 1: Period 1
COMPLETED
|
4
|
3
|
4
|
5
|
4
|
3
|
|
Part 1: Period 1
NOT COMPLETED
|
1
|
2
|
2
|
0
|
1
|
2
|
|
Part 1: Period 2
STARTED
|
4
|
3
|
4
|
5
|
4
|
3
|
|
Part 1: Period 2
COMPLETED
|
4
|
3
|
3
|
5
|
4
|
3
|
|
Part 1: Period 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1: Period 3
STARTED
|
4
|
3
|
3
|
5
|
4
|
3
|
|
Part 1: Period 3
COMPLETED
|
4
|
2
|
3
|
5
|
3
|
2
|
|
Part 1: Period 3
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Sequence ABC
MK-8266 1.3 mg BID, then MK-8266 0.9 mg FDD, then Placebo
|
Sequence ACB
MK-8266 1.3 mg BID, then Placebo, then MK-8266 0.9 mg FDD
|
Sequence BCA
MK-8266 0.9 mg FDD, then Placebo, then MK-8266 1.3 mg BID
|
Sequence BAC
MK-8266 0.9 mg FDD, then MK-8266 1.3 mg BID, then Placebo
|
Sequence CAB
Placebo, then MK-8266 1.3 mg BID, then MK-8266 0.9 mg FDD
|
Sequence CBA
Placebo, then MK-8266 0.9 mg FDD, then MK-8266 1.3 mg BID
|
|---|---|---|---|---|---|---|
|
Part 1: Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 1: Period 1
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Part 1: Period 1
Fulfilled Stopping Criteria
|
1
|
0
|
2
|
0
|
1
|
1
|
|
Part 1: Period 2
Fulfilled Stopping Criteria
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 1: Period 3
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 1: Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 1: Period 3
Protocol Deviation
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Total of 31 participants in Sequences A, B, and C
Baseline characteristics by cohort
| Measure |
All Participants, All Sequences
n=31 Participants
A: MK-8266 1.3 mg BID, B: MK-8266 0.9 mg FDD, C: Placebo
|
|---|---|
|
Age, Continuous
|
49.1 Years
STANDARD_DEVIATION 6.7 • n=5 Participants • Total of 31 participants in Sequences A, B, and C
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Heart Rate (HR)
|
78.00 Beats per minute
STANDARD_DEVIATION 8.77 • n=5 Participants • All participants who were randomized to receive study treatment and had HR measurement
|
|
Diastolic Blood Pressure (DBP)
|
93.36 mmHg
STANDARD_DEVIATION 5.08 • n=5 Participants • All participants who were randomized to receive study treatment and had DBP measurement
|
PRIMARY outcome
Timeframe: MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE was reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placeboPopulation: All participants who received at least one dose of study treatment
The number of participants with one or more clinical or laboratory AEs was assessed. 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 SPONSOR's product, whether or not considered related to the use of the product.
Outcome measures
| Measure |
MK-8266 1.3 mg BID
n=25 Participants
Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 0.9 mg FDD
n=26 Participants
Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 1 mg QD
n=26 Participants
Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.
|
Placebo
n=27 Participants
Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.
|
|---|---|---|---|---|
|
Adverse Events (AEs)
|
9 Participants
|
16 Participants
|
8 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, and 8 hours after dosing on Day 1, and pre-dose and 4 and 8 hours after dosing on Day 3 of each periodPopulation: All participants who received at least one dose of the investigational drug and had assessment of AUC(0-8 hours)
The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.
Outcome measures
| Measure |
MK-8266 1.3 mg BID
n=24 Participants
Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 0.9 mg FDD
n=24 Participants
Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 1 mg QD
Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.
|
Placebo
Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.
|
|---|---|---|---|---|
|
Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Days 1 and 3
Day 1
|
83.4 nM*hr
Standard Deviation 22.2
|
23.7 nM*hr
Standard Deviation 5.96
|
—
|
—
|
|
Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Days 1 and 3
Day 3
|
120 nM*hr
Standard Deviation 41.7
|
69.3 nM*hr
Standard Deviation 25.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 2, 4, and 8 hours after dosing on Day 4 of each periodPopulation: All participants who received at least one dose of the investigational drug and had assessment of AUC(0-8 hours)
The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.
Outcome measures
| Measure |
MK-8266 1.3 mg BID
n=24 Participants
Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 0.9 mg FDD
n=24 Participants
Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 1 mg QD
Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.
|
Placebo
Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.
|
|---|---|---|---|---|
|
Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Day 4
|
135 nM*hr
Standard Deviation 46.6
|
139 nM*hr
Standard Deviation 43.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3Population: All participants who received at least one dose of the investigational drug and had assessment for Cmax
The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.
Outcome measures
| Measure |
MK-8266 1.3 mg BID
n=24 Participants
Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 0.9 mg FDD
n=24 Participants
Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 1 mg QD
Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.
|
Placebo
Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MK-8266 on Day 1 and Day 3
Day 1
|
17.4 mg/mL
Standard Deviation 4.01
|
8.63 mg/mL
Standard Deviation 2.85
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of MK-8266 on Day 1 and Day 3
Day 3
|
20.5 mg/mL
Standard Deviation 6.11
|
11.0 mg/mL
Standard Deviation 3.73
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 2, 4, and 8 hours after dosing on Day 4 of each periodPopulation: All participants who received at least one dose of the investigational drug and had assessment for Cmax
The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.
Outcome measures
| Measure |
MK-8266 1.3 mg BID
n=24 Participants
Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 0.9 mg FDD
n=24 Participants
Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 1 mg QD
Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.
|
Placebo
Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MK-8266 on Day 4
|
23.1 nM
Standard Deviation 7.28
|
23.3 nM
Standard Deviation 6.86
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3Population: All participants who received at least one dose of the investigational drug and had assessment for Tmax
The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 1 and Day 3.
Outcome measures
| Measure |
MK-8266 1.3 mg BID
n=24 Participants
Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 0.9 mg FDD
n=24 Participants
Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 1 mg QD
Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.
|
Placebo
Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 1 and Day 3
Day 1
|
4.0 Hours
Interval 2.0 to 12.0
|
16.0 Hours
Interval 8.0 to 24.0
|
—
|
—
|
|
Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 1 and Day 3
Day 3
|
4.0 Hours
Interval 4.0 to 12.0
|
16.0 Hours
Interval 4.0 to 24.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 2, 4, and 8 hours after dosing on Day 4 of each periodPopulation: All participants who received at least one dose of the investigational drug and had assessment for Tmax
The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 4.
Outcome measures
| Measure |
MK-8266 1.3 mg BID
n=24 Participants
Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 0.9 mg FDD
n=24 Participants
Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 1 mg QD
Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.
|
Placebo
Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.
|
|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 4
|
4.0 Hours
Interval 2.0 to 8.0
|
4.0 Hours
Interval 2.0 to 8.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3Population: All participants who received at least one dose of the investigational drug and had HR measurements
The effect of MK-8266 and placebo on changes in HR were assessed, as measured by time weighted average change from baseline in HR over 0-24 hours postdose (TWA\^0-24 hr) on Day 3. Baseline values for HR are shown in the Baseline Characteristics section.
Outcome measures
| Measure |
MK-8266 1.3 mg BID
n=25 Participants
Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 0.9 mg FDD
n=24 Participants
Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 1 mg QD
n=25 Participants
Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.
|
Placebo
Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.
|
|---|---|---|---|---|
|
Change From Baseline in Heart Rate (HR)
|
2.78 Beats per minute
Standard Deviation 6.67
|
5.84 Beats per minute
Standard Deviation 3.94
|
1.68 Beats per minute
Standard Deviation 3.67
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3Population: All participants who received at least one dose of the investigational drug and had DBP measurements.
The effect of MK-8266 and placebo on changes in diastolic blood pressure (DBP) were assessed, as measured by time weighted average change from baseline in DBP over 0-24 hours postdose (TWA\^0-24 hr) on Day 3. Baseline values for DBP are shown in the Baseline Characteristics section.
Outcome measures
| Measure |
MK-8266 1.3 mg BID
n=25 Participants
Participants receiving MK-8266 1.3 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 0.9 mg FDD
n=24 Participants
Participants receiving MK-8266 0.9 mg BID on Day 1 - Day 3, and MK-8266 1 mg as a single dose on Day 4.
|
MK-8266 1 mg QD
n=24 Participants
Participants receiving MK-8266 administered as a single 1 mg dose on Day 4.
|
Placebo
Participants receiving placebo matching MK-8266 administered on Days 1, 2, 3 and 4.
|
|---|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP)
|
-3.21 mmHg
Standard Deviation 3.77
|
-3.04 mmHg
Standard Deviation 5.30
|
-0.28 mmHg
Standard Deviation 4.68
|
—
|
Adverse Events
MK-8266 1.3 mg BID
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
MK-8266 0.9 mg FDD
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
MK-8266 1 mg QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK-8266 1.3 mg BID
n=25 participants at risk
MK-8266 administered as 1.0 mg in the morning + 0.3 mg 8 hours later on Days 1, 2, and 3
|
MK-8266 0.9 mg FDD
n=26 participants at risk
MK-8266 administered as 0.1 mg every 2 hours on Days 1, 2, and 3
|
MK-8266 1 mg QD
n=26 participants at risk
MK-8266 administered a single 1 mg dose on Day 4
|
Placebo
n=27 participants at risk
Placebo matching MK-8266 administered on Days 1, 2, 3 and 4
|
|---|---|---|---|---|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Cardiac disorders
Palpitations
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
7.7%
2/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Eye disorders
Vision blurred
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.7%
1/27 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Gastrointestinal disorders
Epigastric discomfort
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
11.5%
3/26 • Number of events 3 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
7.7%
2/26 • Number of events 5 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
7.7%
2/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
General disorders
Pyrexia
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
General disorders
Vessel puncture site inflammation
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.7%
1/27 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Infections and infestations
Oral herpes
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.7%
1/27 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Infections and infestations
Rhinitis
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.7%
1/27 • Number of events 8 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.7%
1/27 • Number of events 5 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
7.4%
2/27 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.7%
1/27 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.7%
1/27 • Number of events 3 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Nervous system disorders
Headache
|
16.0%
4/25 • Number of events 6 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
19.2%
5/26 • Number of events 5 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
7.7%
2/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
11.1%
3/27 • Number of events 4 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Nervous system disorders
Hemicephalalgia
|
4.0%
1/25 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Nervous system disorders
Hyperaesthesia
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Nervous system disorders
Migraine
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.7%
1/27 • Number of events 3 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Nervous system disorders
Presyncope
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Nervous system disorders
Tremor
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
7.7%
2/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Psychiatric disorders
Agitation
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Psychiatric disorders
Nervousness
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
4.0%
1/25 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
7.7%
2/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.7%
1/27 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
7.7%
2/26 • Number of events 2 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
4.0%
1/25 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.7%
1/27 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/25 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/26 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
3.8%
1/26 • Number of events 1 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
0.00%
0/27 • MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
|
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 timelines.
- Publication restrictions are in place
Restriction type: OTHER