Phase 1
Completed N=24
A Study of Single Dose MK-3614 (MK-3614-001)(COMPLETED)
Source: ClinicalTrials.gov NCT01104545 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Percentage of Participants Who Reported 1 or More Adverse Event (AE) - Healthy Participants — 100.0; 100.0; 80.0; 33.3 Percentage of Participants
Summary
This study will determine if MK-3614, given as single doses, is safe and well tolerated in healthy males and male participants with mild to moderate hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Reported 1 or More Adverse Event (AE) - Healthy Participants |
100.0; 100.0; 80.0; 33.3; 66.7; 66.7 | — |
| PRIMARY Percentage of Participants Who Were Discontinued From the Study Due to an AE - Healthy Participants |
0.0; 0.0; 0.0; 0.0; 0.0; 16.7 | — |
| PRIMARY Percentage of Participants Who Report 1 or More Adverse Event (AE) - Hypertensive Participants |
75.0; 60.0; 57.1 | — |
| PRIMARY Percentage of Participants Who Were Discontinued From the Study Due to an AE - Hypertensive Participants |
12.5; 0.0; 14.3 | — |
| PRIMARY Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Healthy Participants |
83.8; 412.0; 83.8; 223.0; 173.0; 168.0 | — |
| PRIMARY Maximum Concentration (Cmax) of MK-3614- Healthy Participants |
4.9; 29.8; 3.6; 17.0; 11.5; 13.4 | — |
| PRIMARY Time to Cmax (Tmax) of MK-3614- Healthy Participants |
4.0; 4.0; 6.0; 4.0; 4.0; 4.0 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) of MK-3614- Healthy Participants |
9.2; 10.1; 13.1; 9.1; 9.7; 9.5 | — |
| PRIMARY Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Hypertensive Participants |
253.0; 134.0 | — |
| PRIMARY Maximum Concentration (Cmax) of MK-3614- Hypertensive Participants |
19.1; 10.9 | — |
| PRIMARY Time to Cmax (Tmax) of MK-3614- Hypertensive Participants |
4.0; 4.0 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) of MK-3614 of MK-3614- Hypertensive Participants |
9.1; 8.7 | — |
| PRIMARY Change From Baseline in Heart Rate - Healthy Participants |
-4.7; -0.6; 5.4; 2.5; -0.3; 6.3 | — |
| PRIMARY Change From Baseline in Brachial Arterial Systolic Blood Pressure - Healthy Participants |
-3.3; 2.4; -2.6; -1.0; -3.1; -3.0 | — |
| PRIMARY Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Healthy Participants |
-1.7; 0.8; -2.8; -1.0; -1.8; 3.2 | — |
| PRIMARY Change From Baseline in Heart Rate - Hypertensive Participants |
0.7; 0.8; -8.4 | — |
| PRIMARY Change From Baseline in Brachial Arterial Systolic Blood Pressure - Hypertensive Participants |
-5.2; -10.0; -18.1 | — |
| PRIMARY Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Hypertensive Participants |
0.3; -4.4; -9.1 | — |
| SECONDARY Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed |
83.8; 83.8 | — |
| SECONDARY Maximum Concentration (Cmax) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed |
4.85; 3.56 | — |
| SECONDARY Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Healthy Participants |
-4.7; -5.2; -0.8; -1.8; -3.0; -1.5 | — |
| SECONDARY Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Hypertensive Participants |
2.0; -2.3; 1.1 | — |
| SECONDARY Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose - Healthy Participants |
— | — |
| SECONDARY Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose- Hypertension Participants |
— | — |
| SECONDARY Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Healthy Participants |
0.1; 0.0; 0.2; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Hypertension Participants |
0.2; 0.0 | — |
| SECONDARY Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Healthy Participants |
-22.3; -5.0 | — |
| SECONDARY Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Hypertensive Participants |
-9.3; -19.5 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy participants between 18 to 45 years of age; otherwise healthy participants between 18 to 55 years of age newly diagnosed with grade 1 or 2 hypertension
- Participant is in good general health
- Participant is a nonsmoker
Exclusion Criteria
- Participant has a history of stroke, seizure or major neurological disease
- Participant has functional disability that can interfere with rising from a sitting position to a standing position
- Participant has a family history of a bleeding or clotting disorder
- Participant has a history of cancer
- Participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
- Participant consumes excessive amounts of alcohol or caffeine
- Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks.
Data sourced from ClinicalTrials.gov (NCT01104545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.