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

• Status: Completed
• Trial end date: 2010-05-14
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• For Panel A and B Participant is a healthy male between 18 to 45 years of age. For Panel C Participant is a male with essential hypertension between 18 to 55 years of age

• A non-smoker

Exclusion Criteria:

• Has a history of stroke, chronic seizure or major neurological disorder

• Has a disability that can interfere with rising from a sitting position to the standing position

• Has a personal of family history of bleeding or clotting disorders

• Has a history of cancer

• Is unable to refrain from or anticipates the use of any prescription or nonprescription drug during the study

• Consumes excessive amounts of caffeine or alcohol

• Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks