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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001281-15 | EudraCT Number |
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This study will evaluate the safety and tolerability of MK-8150 and its effect on central systolic blood pressure (cSBP) and heart rate corrected augmentation index (AIx) when given as single oral doses in healthy males and in males with mild-to-moderate hypertension. A primary study hypothesis is that post dose mean change from baseline of time-weighted average across 24 hours (TWA0-24hrs) cSBP or AIx is reduced in participants administered MK-8150 compared to placebo in males with mild to moderate hypertension. A mean decrease from baseline compared to placebo of ≥5 mm Hg in TWA0-24hrs cSBP or of ≥5 percentage points in TWA0-24hrs AIx is considered clinically meaningful.
Up to three planned panels (A, B and C) of either 8 healthy participants or 8 participants with mild to moderate hypertension will be enrolled. For Panel A and Panel B, dosing will occur in an alternating fashion between Panel A and Panel B with dosing commencing in Panel A. Participants will receive alternating single rising oral doses of MK-8150 or placebo in up to 5 treatment periods (Periods 1 through 5). Subsequent doses in any Panel will be administered only after careful evaluation of safety, tolerability, and pharmacodynamic effects of a given dose. For Panel C, participants will receive single rising oral doses of MK-8150 or placebo in up to 5 treatment periods (Periods 1 through 5). Depending on safety, tolerability and hemodynamic effects observed in the healthy participants, Panels A and/or B may be truncated and dosing may proceed in Panel C with hypertensive participants. In this case, dosing of hypertensive participants in Panel C will start with the second highest dose achieved in healthy participants.
Amendment 1 of the protocol added Panel D (healthy males) based on the pharmacokinetic, pharmacodynamic and safety results from Panels A-C. Participants in Panel D will receive single rising oral doses of MK-8150 or placebo in up to 5 treatment periods (Periods 1 through 5) at a dose range of 50 mg to 500 mg of MK-8150. Each treatment period will be approximately 3-4 days apart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A-Healthy | Experimental | Within each of the 5 treatment periods, 6 participants will be randomly assigned to receive MK-8150, and 2 will be randomly assigned to receive matching placebo according to a computer-generated allocation schedule. The dose range of MK-8150 for Panel A will be 2.0 mg to 90 mg. |
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| Panel B-Healthy | Experimental | Within each of the 5 treatment periods, 6 participants will be randomly assigned to receive MK-8150, and 2 will be randomly assigned to receive matching placebo according to a computer-generated allocation schedule. The dose range of MK-8150 for Panel B will be 5.0 mg to 160 mg. |
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| Panel C-Mild/Moderate Hypertension | Experimental | Within each of the 5 treatment periods, 6 participants will be randomly assigned to receive MK-8150, and 2 will be randomly assigned to receive matching placebo according to a computer-generated allocation schedule. The dose range of MK-8150 for Panel C will be 160 mg to 1200 mg. |
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| Panel D-Healthy | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8150 2.0 mg | Drug | Single oral 2.0-mg dose of MK-8150 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event (AE) | 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. | Up to 14 days after the last dose (Up to approximately 42 days) |
| Number of Participants Who Discontinued Study Due to an AE | 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. | Up to 14 days after the last dose (Up to approximately 42 days) |
| 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) | 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. | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27561272 | Result | Knox CD, de Kam PJ, Azer K, Wong P, Ederveen AG, Shevell D, Morabito C, Meehan AG, Liu W, Reynders T, Denef JF, Mitselos A, Jonathan D, Gutstein DE, Mitra K, Sun SY, Lo MM, Cully D, Ali A. Discovery and Clinical Evaluation of MK-8150, A Novel Nitric Oxide Donor With a Unique Mechanism of Nitric Oxide Release. J Am Heart Assoc. 2016 Aug 25;5(9):e003493. doi: 10.1161/JAHA.116.003493. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Within each panel, 8 subjects will be randomly assigned to MK-8150 and 2 subjects will be randomly assigned to placebo throughout the 5 periods according to a computer-generated allocation schedule. The dose range of MK-8150 for Panel D will be 50 mg to 500 mg. |
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| MK-8150 10 mg |
| Drug |
Single oral 10-mg dose of MK-8150 |
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| MK-8150 40 mg | Drug | Single oral 40-mg dose of MK-8150 without food (fasted) and with food (fed) |
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| MK-8150 90 mg | Drug | Single oral 90-mg dose of MK-8150 |
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| MK-8150 5.0 mg | Drug | Single oral 5.0-mg dose of MK-8150 |
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| MK-8150 20 mg | Drug | Single oral 20-mg dose of MK-8150 |
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| MK-8150 60 mg | Drug | Single oral 60-mg dose of MK-8150 |
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| MK-8150 120 mg | Drug | Single oral 120-mg dose of MK-8150 |
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| MK-8150 160 mg | Drug | Single oral 160-mg dose of MK-8150 |
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| MK-8150 320 mg | Drug | Single oral 320-mg dose of MK-8150 |
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| MK-8150 600 mg | Drug | Single oral 600-mg dose of MK-8150 |
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| MK-8150 900 mg | Drug | Single oral 900-mg dose of MK-8150 |
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| MK-8150 1200 mg | Drug | Single oral 1200-mg dose of MK-8150 |
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| Placebo for MK-8150 | Drug | Single oral dose-matched dose of Placebo for MK-8150 |
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| MK-8150 50 mg | Drug | Single oral 50-mg dose of MK-8150 |
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| MK-8150 100 mg | Drug | Single oral 100-mg dose of MK-8150 |
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| MK-8150 200 mg | Drug | Single oral 200-mg dose of MK-8150 |
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| MK-8150 400 mg | Drug | Single oral 400-mg dose of MK-8150 |
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| MK-8150 500 mg | Drug | Single oral 500-mg dose of MK-8150 |
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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. |
| Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| 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) | 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. | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A) | 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. | 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 dose |
| Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| 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) | 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. | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| 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) | 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. | 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 dose |
| Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | 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 dose |
| 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) | 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. | 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 dose |
| Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | 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 dose |
| Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A) | 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. | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| 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) | 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. | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
| Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A) | 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. | 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 dose |
| Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | 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 dose |
| 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) | 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. | 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 dose |
| Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | 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 dose |
| Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A) | 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. | 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 dose |
| Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | 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 dose |
| 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) | 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. | 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 dose |
| Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | 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 dose |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Central Systolic Blood Pressure (cSBP) | Mean | Standard Deviation | mm Hg |
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| Augmentation Index (AIx) | 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. AIx is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. | Mean | Standard Deviation | percentage of central pulse pressure |
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| Heart Rate (HR) | Mean | Standard Deviation | beats per minute |
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| Central Diastolic Blood Pressure (cDBP) | Mean | Standard Deviation | mm Hg |
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| Peripheral Systolic Blood Pressure (pSBP) | Mean | Standard Deviation | mm Hg |
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| Peripheral Diastolic Blood Pressure (pDBP) | Mean | Standard Deviation | mm Hg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With an Adverse Event (AE) | 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. | All participants who received a dose of study drug | Posted | Number | participants | Up to 14 days after the last dose (Up to approximately 42 days) |
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| Primary | Number of Participants Who Discontinued Study Due to an AE | 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. | All participants who received a dose of study drug | Posted | Number | participants | Up to 14 days after the last dose (Up to approximately 42 days) |
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| Primary | 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) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | 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) | 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. | Per-Protocol population | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A) | 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. | 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) | Posted | Least Squares Mean | Standard Error | percentage of central pulse pressure | 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 dose |
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| Primary | Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | 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) | Posted | Least Squares Mean | Standard Error | percentage of central pulse pressure | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | 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) | 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. | Per-Protocol population | Posted | Least Squares Mean | Standard Error | percentage of central pulse pressure | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | 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) | Posted | Least Squares Mean | Standard Error | percentage of central pulse pressure | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | 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) | 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. | 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) | Posted | Least Squares Mean | Standard Error | beats per minute | 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 dose |
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| Primary | Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | 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) | Posted | Least Squares Mean | Standard Error | beats per minute | 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 dose |
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| Primary | 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) | 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. | Per-Protocol population | Posted | Least Squares Mean | Standard Error | beats per minute | 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 dose |
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| Primary | Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | 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) | Posted | Least Squares Mean | Standard Error | beats per minute | 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 dose |
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| Primary | Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | 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) | 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. | Per-Protocol population | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose |
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| Primary | Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | 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 dose |
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| Primary | Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | 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 dose |
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| Primary | 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) | 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. | Per-Protocol population | Posted | Least Squares Mean | Standard Error | mm Hg | 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 dose |
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| Primary | Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | 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 dose |
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| Primary | Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | 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 dose |
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| Primary | Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | 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 dose |
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| Primary | 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) | 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. | Per-Protocol population | Posted | Least Squares Mean | Standard Error | mm Hg | 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 dose |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D) | 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. | 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) | Posted | Least Squares Mean | Standard Error | mm Hg | 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 dose |
|
Up to 14 days after the last dose (Up to approximately 42 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 8 | 8 | 8 | ||
| EG001 | 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. | 0 | 8 | 8 | 8 | ||
| EG002 | 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. | 0 | 8 | 7 | 8 | ||
| EG003 | Panel D - MK-8150 50 to 200 mg | 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. | 0 | 8 | 7 | 8 | ||
| EG004 | 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. | 0 | 2 | 2 | 2 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Postural orthostatic tachycardia syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Loose stools | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Common cold | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Laceration of finger | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Orthostatic heart rate response increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| White blood cells urine increased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myalgia of lower extremities | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain ankle | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain in elbow | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diastolic hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hot flushes facial | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Systolic hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000092244 | Isolated Systolic Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000075222 | Essential Hypertension |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625933 | MK-8150 |
Not provided
Not provided
Not provided
| Male |
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | Panel A - MK-8150 24 mg | Single dose of MK-8150 24 mg |
| OG003 | Panel A - MK-8150 24 mg (Fed Condition) | Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast. |
| OG004 | Panel A - MK-8150 90 mg | Single dose of MK-8150 90 mg |
| OG005 | Panel A - Placebo | Single dose of placebo |
|
|
|
| OG002 | Panel B - MK-8150 45 mg | Single dose of MK-8150 45 mg |
| OG003 | Panel B - MK-8150 120 mg | Single dose of MK-8150 120 mg |
| OG004 | Panel B - MK-8150 120 mg (Repeat Dose) | Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol |
| OG005 | Panel B - Placebo | Single dose of placebo |
|
|
|
| OG003 | Panel C - Placebo | Single dose of placebo |
|
|
|
| OG002 | Panel D - MK-8150 100 mg | Single dose of MK-8150 100 mg |
| OG003 | Panel D - MK-8150 200 mg | Single dose of MK-8150 200 mg |
| OG004 | Panel D - Placebo | Single dose of placebo |
|
|
|
| OG001 |
| Panel A - MK-8150 6 mg |
Single dose of MK-8150 6 mg |
| OG002 | Panel A - MK-8150 24 mg | Single dose of MK-8150 24 mg |
| OG003 | Panel A - MK-8150 24 mg (Fed Condition) | Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast. |
| OG004 | Panel A - MK-8150 90 mg | Single dose of MK-8150 90 mg |
| OG005 | Panel A - Placebo | Single dose of placebo |
|
|
|
| Panel B - MK-8150 12 mg |
Single dose of MK-8150 12 mg |
| OG002 | Panel B - MK-8150 45 mg | Single dose of MK-8150 45 mg |
| OG003 | Panel B - MK-8150 120 mg | Single dose of MK-8150 120 mg |
| OG004 | Panel B - MK-8150 120 mg (Repeat Dose) | Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol |
| OG005 | Panel B - Placebo | Single dose of placebo |
|
|
|
| Panel C - MK-8150 90 mg |
Single dose of MK-8150 90 mg |
| OG003 | Panel C - Placebo | Single dose of placebo |
|
|
|
Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol |
| OG002 | Panel D - MK-8150 100 mg | Single dose of MK-8150 100 mg |
| OG003 | Panel D - MK-8150 200 mg | Single dose of MK-8150 200 mg |
| OG004 | Panel D - Placebo | Single dose of placebo |
|
|
|
| OG002 |
| Panel A - MK-8150 24 mg |
Single dose of MK-8150 24 mg |
| OG003 | Panel A - MK-8150 24 mg (Fed Condition) | Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast. |
| OG004 | Panel A - MK-8150 90 mg | Single dose of MK-8150 90 mg |
| OG005 | Panel A - Placebo | Single dose of placebo |
|
|
|
| Panel B - MK-8150 45 mg |
Single dose of MK-8150 45 mg |
| OG003 | Panel B - MK-8150 120 mg | Single dose of MK-8150 120 mg |
| OG004 | Panel B - MK-8150 120 mg (Repeat Dose) | Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol |
| OG005 | Panel B - Placebo | Single dose of placebo |
|
|
|
| Panel C - Placebo |
Single dose of placebo |
|
|
|
| Panel D - MK-8150 100 mg |
Single dose of MK-8150 100 mg |
| OG003 | Panel D - MK-8150 200 mg | Single dose of MK-8150 200 mg |
| OG004 | Panel D - Placebo | Single dose of placebo |
|
|
|
| OG002 | Panel A - MK-8150 24 mg | Single dose of MK-8150 24 mg |
| OG003 | Panel A - MK-8150 24 mg (Fed Condition) | Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast. |
| OG004 | Panel A - MK-8150 90 mg | Single dose of MK-8150 90 mg |
| OG005 | Panel A - Placebo | Single dose of placebo |
|
|
|
| OG002 | Panel B - MK-8150 45 mg | Single dose of MK-8150 45 mg |
| OG003 | Panel B - MK-8150 120 mg | Single dose of MK-8150 120 mg |
| OG004 | Panel B - MK-8150 120 mg (Repeat Dose) | Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol |
| OG005 | Panel B - Placebo | Single dose of placebo |
|
|
|
| OG003 | Panel C - Placebo | Single dose of placebo |
|
|
|
| OG002 | Panel D - MK-8150 100 mg | Single dose of MK-8150 100 mg |
| OG003 | Panel D - MK-8150 200 mg | Single dose of MK-8150 200 mg |
| OG004 | Panel D - Placebo | Single dose of placebo |
|
|
|
| Panel A - MK-8150 24 mg |
Single dose of MK-8150 24 mg |
| OG003 | Panel A - MK-8150 24 mg (Fed Condition) | Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast. |
| OG004 | Panel A - MK-8150 90 mg | Single dose of MK-8150 90 mg |
| OG005 | Panel A - Placebo | Single dose of placebo |
|
|
|
| Panel B - MK-8150 45 mg |
Single dose of MK-8150 45 mg |
| OG003 | Panel B - MK-8150 120 mg | Single dose of MK-8150 120 mg |
| OG004 | Panel B - MK-8150 120 mg (Repeat Dose) | Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol |
| OG005 | Panel B - Placebo | Single dose of placebo |
|
|
|
| OG003 |
| Panel C - Placebo |
Single dose of placebo |
|
|
|
| OG002 |
| Panel D - MK-8150 100 mg |
Single dose of MK-8150 100 mg |
| OG003 | Panel D - MK-8150 200 mg | Single dose of MK-8150 200 mg |
| OG004 | Panel D - Placebo | Single dose of placebo |
|
|
|
| Panel A - MK-8150 24 mg |
Single dose of MK-8150 24 mg |
| OG003 | Panel A - MK-8150 24 mg (Fed Condition) | Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast. |
| OG004 | Panel A - MK-8150 90 mg | Single dose of MK-8150 90 mg |
| OG005 | Panel A - Placebo | Single dose of placebo |
|
|
|
| Panel B - MK-8150 45 mg |
Single dose of MK-8150 45 mg |
| OG003 | Panel B - MK-8150 120 mg | Single dose of MK-8150 120 mg |
| OG004 | Panel B - MK-8150 120 mg (Repeat Dose) | Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol |
| OG005 | Panel B - Placebo | Single dose of placebo |
|
|
|
| OG003 |
| Panel C - Placebo |
Single dose of placebo |
|
|
|
| OG002 |
| Panel D - MK-8150 100 mg |
Single dose of MK-8150 100 mg |
| OG003 | Panel D - MK-8150 200 mg | Single dose of MK-8150 200 mg |
| OG004 | Panel D - Placebo | Single dose of placebo |
|
|
|