A Single Dose Study of MK-8266 (MK-8266-001)

Summary

A three panel study, to determine if MK-8266 given as a single dose is sufficiently safe and well tolerated. Panel A and B will consist of healthy young males and Panel C will consist of subjects with mild to moderate hypertension. The primary hypotheses for the study are that MK-8266 given as single doses is sufficiently safe and well tolerated to permit continued clinical investigation in healthy young male volunteers and male participants with mild-to-moderate hypertension and that in males with mild to moderate hypertension, at a single oral dose of MK-8266 that is sufficiently safe and well-tolerated, postdose mean time-weighted average across 24 hours of aortic augmentation index (TWA0-12hrs AIx) is reduced compared to placebo. A mean decrease of ≥ 5 percentage points is considered clinically meaningful.

Timeline

Start

2009-11-18

Primary completion

2010-05-14

Completion

2010-05-14

Outcome

Met primary endpoint

registry Panel C MK-8266 1.0/0.8 mg (Mild/Mod. Hypertension) vs Panel C Placebo; p = 0.001; 1 mg + 0.8 mg vs. placebo -9.31 (90% CI -14.2 to -4.37); ANOVA NCT01025791 ↗

Drugs

Indications