Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Male

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.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Candesartan; Candesartan cilexetil

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