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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001680-23 | EudraCT Number | ||
| MK-8892-003 | Other Identifier | Merck Protocol Number |
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This clinical trial will study the safety, tolerability, and pharmacodynamics of single doses of MK-8892 in participants with pulmonary arterial hypertension (PAH). The primary objective is to estimate the measured peak effect of the highest acutely tolerated (HAT) single oral dose of MK-8892 on pulmonary vascular resistance (PVR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mg MK-8892 | Experimental | Participants will receive a single oral dose of 1 mg MK-8892. |
|
| 4 mg MK-8892 | Experimental | Participants will receive a single oral dose of 4 mg MK-8892. |
|
| 8 mg MK-8892 | Experimental | Participants will receive a single oral dose of 8 mg MK-8892. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8892 | Drug | Single oral capsule with 1 mg, 4 mg, or 8 mg of MK-8892 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Percent Change From Baseline in Pulmonary Vascular Resistance (PVR) at the Highest Acutely Tolerated (HAT) Dose of MK-8892 | PVR assessments were performed throughout the right heart catheterization (RHC). Peak PVR reduction was determined to occur if 2 consecutive PVR measurements were at least 20% greater than the nadir PVR measurement. | Baseline and up to 5 hours post-dose |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | 1 mg MK-8892 | Participants received a single oral dose of 1 mg MK-8892. |
| FG001 | 4 mg MK-8892 | Participants received a single oral dose of 4 mg MK-8892. |
| FG002 | 8 mg MK-8892 | Participants received a single oral dose of 8 mg MK-8892. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 mg MK-8892 | Participants received a single oral dose of 1 mg MK-8892. |
| BG001 | 4 mg MK-8892 | Participants received a single oral dose of 4 mg MK-8892. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Percent Change From Baseline in Pulmonary Vascular Resistance (PVR) at the Highest Acutely Tolerated (HAT) Dose of MK-8892 | PVR assessments were performed throughout the right heart catheterization (RHC). Peak PVR reduction was determined to occur if 2 consecutive PVR measurements were at least 20% greater than the nadir PVR measurement. | Planned efficacy analysis could not be performed due to early study termination. | Posted | Baseline and up to 5 hours post-dose |
|
Up to 14 days after study drug administration
Safety analysis included all participants who received at least one dose of study drug.
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| 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: 1 mg | Participants received a single oral dose of 1 mg MK-8892. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| BG002 | 8 mg MK-8892 | Participants received a single oral dose of 8 mg MK-8892. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | 8 mg MK-8892 | Participants received a single oral dose of 8 mg MK-8892. |
|
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Panel B: 4 mg | Participants received a single oral dose of 4 mg MK-8892. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Panel C: 8 mg | Participants received a single oral dose of 8 mg MK-8892. | 0 | 3 | 0 | 3 | 0 | 3 |
| Blood pressure increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.