Trial Outcomes & Findings for A Single Rising Dose Study of MK-8150 (MK-8150-001) (NCT NCT01590810)
NCT ID: NCT01590810
Last Updated: 2018-09-25
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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
COMPLETED
PHASE1
34 participants
Up to 14 days after the last dose (Up to approximately 42 days)
2018-09-25
Participant Flow
Participant milestones
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
2
|
|
Overall Study
COMPLETED
|
8
|
7
|
7
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Single Rising Dose Study of MK-8150 (MK-8150-001)
Baseline characteristics by cohort
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=8 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=2 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
34.8 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
39.0 years
STANDARD_DEVIATION 12.7 • n=21 Participants
|
42 years
STANDARD_DEVIATION 10 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
|
Central Systolic Blood Pressure (cSBP)
|
98 mm Hg
STANDARD_DEVIATION 7 • n=5 Participants
|
98 mm Hg
STANDARD_DEVIATION 6 • n=7 Participants
|
125 mm Hg
STANDARD_DEVIATION 8 • n=5 Participants
|
102 mm Hg
STANDARD_DEVIATION 9 • n=4 Participants
|
105 mm Hg
STANDARD_DEVIATION 6 • n=21 Participants
|
106 mm Hg
STANDARD_DEVIATION 13 • n=10 Participants
|
|
Augmentation Index (AIx)
|
7 percentage of central pulse pressure
STANDARD_DEVIATION 3 • n=5 Participants
|
8 percentage of central pulse pressure
STANDARD_DEVIATION 4 • n=7 Participants
|
22 percentage of central pulse pressure
STANDARD_DEVIATION 8 • n=5 Participants
|
10 percentage of central pulse pressure
STANDARD_DEVIATION 11 • n=4 Participants
|
8 percentage of central pulse pressure
STANDARD_DEVIATION 12 • n=21 Participants
|
12 percentage of central pulse pressure
STANDARD_DEVIATION 9 • n=10 Participants
|
|
Heart Rate (HR)
|
58 beats per minute
STANDARD_DEVIATION 7 • n=5 Participants
|
54 beats per minute
STANDARD_DEVIATION 5 • n=7 Participants
|
67 beats per minute
STANDARD_DEVIATION 9 • n=5 Participants
|
61 beats per minute
STANDARD_DEVIATION 7 • n=4 Participants
|
45 beats per minute
STANDARD_DEVIATION 1 • n=21 Participants
|
59 beats per minute
STANDARD_DEVIATION 9 • n=10 Participants
|
|
Central Diastolic Blood Pressure (cDBP)
|
85 mm Hg
STANDARD_DEVIATION 6 • n=5 Participants
|
84 mm Hg
STANDARD_DEVIATION 6 • n=7 Participants
|
107 mm Hg
STANDARD_DEVIATION 6 • n=5 Participants
|
86 mm Hg
STANDARD_DEVIATION 8 • n=4 Participants
|
91 mm Hg
STANDARD_DEVIATION 6 • n=21 Participants
|
91 mm Hg
STANDARD_DEVIATION 11 • n=10 Participants
|
|
Peripheral Systolic Blood Pressure (pSBP)
|
119 mm Hg
STANDARD_DEVIATION 5 • n=5 Participants
|
119 mm Hg
STANDARD_DEVIATION 6 • n=7 Participants
|
148 mm Hg
STANDARD_DEVIATION 7 • n=5 Participants
|
125 mm Hg
STANDARD_DEVIATION 8 • n=4 Participants
|
126 mm Hg
STANDARD_DEVIATION 12 • n=21 Participants
|
128 mm Hg
STANDARD_DEVIATION 14 • n=10 Participants
|
|
Peripheral Diastolic Blood Pressure (pDBP)
|
75 mm Hg
STANDARD_DEVIATION 6 • n=5 Participants
|
73 mm Hg
STANDARD_DEVIATION 6 • n=7 Participants
|
94 mm Hg
STANDARD_DEVIATION 6 • n=5 Participants
|
75 mm Hg
STANDARD_DEVIATION 8 • n=4 Participants
|
80 mm Hg
STANDARD_DEVIATION 7 • n=21 Participants
|
79 mm Hg
STANDARD_DEVIATION 10 • n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after the last dose (Up to approximately 42 days)Population: All participants who received a 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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=8 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=2 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Number of Participants With an Adverse Event (AE)
|
8 participants
|
8 participants
|
7 participants
|
7 participants
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: Up to 14 days after the last dose (Up to approximately 42 days)Population: All participants who received a 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 study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=8 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=2 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Due to an AE
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=6 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
|
1.33 mm Hg
Standard Error 0.99
|
-1.65 mm Hg
Standard Error 1.31
|
-7.69 mm Hg
Standard Error 1.71
|
-6.29 mm Hg
Standard Error 1.82
|
-9.86 mm Hg
Standard Error 1.66
|
0.55 mm Hg
Standard Error 1.08
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=5 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=5 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
|
-5.06 mm Hg
Standard Error 0.91
|
-7.64 mm Hg
Standard Error 1.50
|
-11.67 mm Hg
Standard Error 1.68
|
-14.20 mm Hg
Standard Error 1.60
|
-11.91 mm Hg
Standard Error 1.26
|
-2.18 mm Hg
Standard Error 1.11
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population
cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
|
-11.69 mm Hg
Standard Error 3.01
|
-18.38 mm Hg
Standard Error 4.47
|
-25.11 mm Hg
Standard Error 3.20
|
-7.60 mm Hg
Standard Error 4.46
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=8 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=2 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
|
-16.23 mm Hg
Standard Error 1.40
|
-13.22 mm Hg
Standard Error 1.55
|
-15.84 mm Hg
Standard Error 1.50
|
-15.86 mm Hg
Standard Error 1.47
|
-3.02 mm Hg
Standard Error 0.38
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose; except Period 1: Pre-dose and 2, 4, 12 and 24 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=6 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
|
-0.75 percentage of central pulse pressure
Standard Error 1.99
|
-0.67 percentage of central pulse pressure
Standard Error 1.63
|
-10.06 percentage of central pulse pressure
Standard Error 1.62
|
-6.59 percentage of central pulse pressure
Standard Error 2.22
|
-15.22 percentage of central pulse pressure
Standard Error 1.53
|
1.56 percentage of central pulse pressure
Standard Error 1.32
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=5 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=5 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
|
-3.04 percentage of central pulse pressure
Standard Error 1.55
|
-6.85 percentage of central pulse pressure
Standard Error 1.83
|
-13.57 percentage of central pulse pressure
Standard Error 2.54
|
-18.42 percentage of central pulse pressure
Standard Error 1.55
|
-16.33 percentage of central pulse pressure
Standard Error 2.22
|
-0.09 percentage of central pulse pressure
Standard Error 1.50
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population
AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
|
-8.32 percentage of central pulse pressure
Standard Error 1.69
|
-12.09 percentage of central pulse pressure
Standard Error 3.25
|
-21.03 percentage of central pulse pressure
Standard Error 1.90
|
-6.73 percentage of central pulse pressure
Standard Error 2.49
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=8 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=2 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
|
-13.83 percentage of central pulse pressure
Standard Error 1.54
|
-12.04 percentage of central pulse pressure
Standard Error 1.46
|
-15.09 percentage of central pulse pressure
Standard Error 1.12
|
-14.42 percentage of central pulse pressure
Standard Error 1.29
|
-1.46 percentage of central pulse pressure
Standard Error 0.17
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=6 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average Across 12 Hours (TWA0-12hrs) HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
|
2.94 beats per minute
Standard Error 1.31
|
4.08 beats per minute
Standard Error 1.61
|
4.07 beats per minute
Standard Error 1.47
|
7.54 beats per minute
Standard Error 2.19
|
4.04 beats per minute
Standard Error 1.65
|
1.89 beats per minute
Standard Error 1.43
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=5 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=5 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
|
-0.26 beats per minute
Standard Error 1.10
|
-0.91 beats per minute
Standard Error 1.57
|
0.66 beats per minute
Standard Error 1.75
|
3.17 beats per minute
Standard Error 0.91
|
5.19 beats per minute
Standard Error 1.45
|
0.57 beats per minute
Standard Error 1.16
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dosePopulation: Per-Protocol population
HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-12hrs HR in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
|
-6.11 beats per minute
Standard Error 2.32
|
-3.74 beats per minute
Standard Error 1.58
|
-1.02 beats per minute
Standard Error 1.75
|
-4.67 beats per minute
Standard Error 2.23
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dosePopulation: Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=8 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=2 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
|
-1.24 beats per minute
Standard Error 1.90
|
-1.09 beats per minute
Standard Error 2.15
|
-0.52 beats per minute
Standard Error 1.59
|
3.83 beats per minute
Standard Error 2.15
|
-5.67 beats per minute
Standard Error 3.66
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=6 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
|
0.74 mm Hg
Standard Error 1.07
|
-1.97 mm Hg
Standard Error 1.46
|
-8.34 mm Hg
Standard Error 1.77
|
-6.73 mm Hg
Standard Error 2.27
|
-10.54 mm Hg
Standard Error 1.62
|
-0.23 mm Hg
Standard Error 1.11
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=5 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=5 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
|
-5.02 mm Hg
Standard Error 1.10
|
-7.76 mm Hg
Standard Error 1.61
|
-11.88 mm Hg
Standard Error 1.75
|
-14.12 mm Hg
Standard Error 1.95
|
-12.21 mm Hg
Standard Error 1.30
|
-2.96 mm Hg
Standard Error 1.33
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population
cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs cDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
|
-10.40 mm Hg
Standard Error 1.96
|
-16.32 mm Hg
Standard Error 3.97
|
-23.65 mm Hg
Standard Error 2.67
|
-8.14 mm Hg
Standard Error 3.76
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dosePopulation: Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=8 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=2 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
|
-15.55 mm Hg
Standard Error 1.05
|
-13.26 mm Hg
Standard Error 0.93
|
-15.35 mm Hg
Standard Error 1.19
|
-15.84 mm Hg
Standard Error 1.10
|
-4.71 mm Hg
Standard Error 0.52
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=6 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
|
0.73 mm Hg
Standard Error 1.35
|
-0.24 mm Hg
Standard Error 1.45
|
-3.13 mm Hg
Standard Error 1.56
|
-1.91 mm Hg
Standard Error 1.42
|
-4.46 mm Hg
Standard Error 1.70
|
1.46 mm Hg
Standard Error 1.41
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=5 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=5 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
|
-4.61 mm Hg
Standard Error 1.00
|
-6.81 mm Hg
Standard Error 1.61
|
-7.16 mm Hg
Standard Error 2.00
|
-8.50 mm Hg
Standard Error 1.39
|
-6.40 mm Hg
Standard Error 1.19
|
-1.17 mm Hg
Standard Error 1.01
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dosePopulation: Per-Protocol population
pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs pSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
|
-12.32 mm Hg
Standard Error 3.88
|
-18.26 mm Hg
Standard Error 4.84
|
-21.42 mm Hg
Standard Error 3.63
|
-5.39 mm Hg
Standard Error 6.63
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dosePopulation: Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=8 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=2 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
|
-12.77 mm Hg
Standard Error 1.14
|
-10.19 mm Hg
Standard Error 1.86
|
-11.19 mm Hg
Standard Error 1.78
|
-10.47 mm Hg
Standard Error 1.79
|
-3.00 mm Hg
Standard Error 0.85
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=6 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)
|
-0.92 mm Hg
Standard Error 0.61
|
-2.58 mm Hg
Standard Error 1.13
|
-8.01 mm Hg
Standard Error 1.56
|
-6.69 mm Hg
Standard Error 2.30
|
-9.85 mm Hg
Standard Error 1.38
|
-1.24 mm Hg
Standard Error 0.90
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dosePopulation: Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)
pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=5 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=5 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
n=8 Participants
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)
|
-3.91 mm Hg
Standard Error 1.02
|
-6.21 mm Hg
Standard Error 1.34
|
-9.64 mm Hg
Standard Error 1.86
|
-11.69 mm Hg
Standard Error 1.85
|
-10.20 mm Hg
Standard Error 1.11
|
-1.90 mm Hg
Standard Error 0.85
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dosePopulation: Per-Protocol population
pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=5 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=6 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=6 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)
|
-7.87 mm Hg
Standard Error 1.89
|
-12.90 mm Hg
Standard Error 3.55
|
-19.82 mm Hg
Standard Error 2.27
|
-6.14 mm Hg
Standard Error 3.80
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dosePopulation: Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)
pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.
Outcome measures
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=8 Participants
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=8 Participants
Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=2 Participants
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
Panel A - Placebo
Single dose of placebo
|
|---|---|---|---|---|---|---|
|
Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)
|
-13.91 mm Hg
Standard Error 0.77
|
-11.65 mm Hg
Standard Error 0.61
|
-13.36 mm Hg
Standard Error 0.87
|
-14.31 mm Hg
Standard Error 0.87
|
-4.79 mm Hg
Standard Error 1.17
|
—
|
Adverse Events
Panel A - MK-8150 2 to 90 mg/Placebo
Panel B - MK-8150 4 to 120 mg/Placebo
Panel C - MK-8150 5 to 90 mg/Placebo
Panel D - MK-8150 50 to 200 mg
Panel D - Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Panel A - MK-8150 2 to 90 mg/Placebo
n=8 participants at risk
Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
|
Panel B - MK-8150 4 to 120 mg/Placebo
n=8 participants at risk
Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
|
Panel C - MK-8150 5 to 90 mg/Placebo
n=8 participants at risk
Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
|
Panel D - MK-8150 50 to 200 mg
n=8 participants at risk
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
|
Panel D - Placebo
n=2 participants at risk
Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
25.0%
2/8 • Number of events 6 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
25.0%
2/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Eye disorders
Conjunctivitis
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
25.0%
2/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Gastrointestinal disorders
Loose stools
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
25.0%
2/8 • Number of events 4 • Up to 14 days after the last dose (Up to approximately 42 days)
|
37.5%
3/8 • Number of events 5 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Gastrointestinal disorders
Regurgitation
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
General disorders
Application site pruritus
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 3 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 5 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
General disorders
Feeling cold
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Infections and infestations
Common cold
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Infections and infestations
Folliculitis
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
50.0%
1/2 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Injury, poisoning and procedural complications
Laceration of finger
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Investigations
Neutrophil count increased
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Investigations
Orthostatic heart rate response increased
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 4 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Investigations
White blood cell count increased
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Investigations
White blood cells urine increased
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 3 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia of lower extremities
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
50.0%
1/2 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Musculoskeletal and connective tissue disorders
Pain ankle
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in elbow
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
50.0%
1/2 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
50.0%
1/2 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
25.0%
2/8 • Number of events 3 • Up to 14 days after the last dose (Up to approximately 42 days)
|
50.0%
1/2 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Nervous system disorders
Headache
|
75.0%
6/8 • Number of events 19 • Up to 14 days after the last dose (Up to approximately 42 days)
|
87.5%
7/8 • Number of events 37 • Up to 14 days after the last dose (Up to approximately 42 days)
|
75.0%
6/8 • Number of events 10 • Up to 14 days after the last dose (Up to approximately 42 days)
|
87.5%
7/8 • Number of events 28 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
50.0%
1/2 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 3 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 4 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
12.5%
1/8 • Number of events 2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Vascular disorders
Diastolic hypertension
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 3 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Vascular disorders
Haematoma
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Vascular disorders
Hot flushes facial
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 1 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 3 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
12.5%
1/8 • Number of events 9 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/8 • Up to 14 days after the last dose (Up to approximately 42 days)
|
0.00%
0/2 • Up to 14 days after the last dose (Up to approximately 42 days)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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