drugset / Trial / NCT01798849

A Rising Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of MK-8892 (MK-8892-001)

NCT01798849 ↗

Phase 1 Completed 25 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate safety, tolerability and effects on central diastolic blood pressure (cDBP) of MK-8892 given as single oral doses in healthy male participants (Panel A and B) and in male participants with mild-to-moderate hypertension (Panel C).

Timeline

Start
2013-03-15
Primary completion
2013-07-17
Completion
2013-07-17

Outcome

Mixed primary results

registry analysis (other test); 6.0 mg MK-8892-Healthy vs Placebo-Healthy; p = 0.002; Difference in LS Means -4.89 NCT01798849 ↗

registry analysis (other test); 0.5 mg MK-8892-Healthy vs Placebo-Healthy; p = 0.732; Difference in Least-square (LS) Means -0.50 NCT01798849 ↗

registry analysis (other test); 2.0 mg MK-8892-Hypertensive vs Placebo-Hypertensive; p = 0.000; Difference in LS means -6.32 NCT01798849 ↗

registry analysis (other test); 0.5 mg MK-8892-Hypertensive vs Placebo-Hypertensive; p = 0.165; Difference in LS means -2.34 NCT01798849 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8892 Unknown 0.5 mg Oral
Subject MK-8892 Unknown 1 mg Oral
Subject MK-8892 Unknown 2 mg Oral
Subject MK-8892 Unknown 4 mg Oral
Subject MK-8892 Unknown 6 mg Oral
Subject MK-8892 Unknown 9 mg Oral
Subject MK-8892 Unknown 12 mg Oral
Subject MK-8892 Unknown 14 mg Oral