Phase 1
Completed N=20
Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)
Source: ClinicalTrials.gov NCT01025843 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Number of Participants With One or More Adverse Events (AEs) — 5; 3; 3; 4 Participants
Summary
This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in participants with hypertension. The primary hypothesis is that single oral doses of MK-5478 are sufficiently safe and well tolerated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Adverse Events (AEs) |
5; 3; 3; 4; 4; 3 | — |
| PRIMARY Number of Participants Who Discontinued Treatment Due to an AE |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan |
0.236; 0.494; 1.87; 1.80; 1.36; 2.23 | — |
| SECONDARY Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan |
— | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan |
0.0291; 0.0573; 0.254; 0.227; 0.120; 0.245 | — |
Eligibility Criteria
Inclusion Criteria
Part I:
- Is a male between 18 to 50 years of age
- Is in good health
- Is a non-smoker
Part II:
- Is male of non-child bearing potential between 18 and 50 years of age
- Has hypertension (high blood pressure)
Exclusion Criteria
Part I and Part II:
- Has a history of stroke, seizures or major neurological disorder
- Has a history of cancer
- Has a history of any cardiovascular disease
- Is unable to refrain from the use of any prescription or non-prescription drugs
- Consumes excessive amounts of alcohol or caffeine
- Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
Data sourced from ClinicalTrials.gov (NCT01025843). 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.