A Multiple Dose Study of MK-3614 (MK-3614-002)

• Status: Completed
• Trial end date: 2009-12-09
• Target enrollment: 0
• Participant gender: Male

Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MK-3614 in male participants with mild to moderate hypertension. The primary hypotheses are: 1) Multiple oral doses of MK-3614 are sufficiently safe and well tolerated to permit continued clinical investigation 2) Aortic Augmentation Index (Aix) is reduced 24 hours post the last dose of MK-3614 administered compared to placebo and 3) Increase in the 12-hour weighted averages (TWA 0-12hours) of the heart rate is within 15 beats per minute (bpm) of baseline on first day of multiple dosing of MK-3614 and within 10 bpm of baseline on last day of multiple dosing of MK-3614.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Has mild to moderate hypertension

• Has grade 1 or 2 arterial hypertension being treated with a single antihypertensive drug

• Has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months; or who have discontinued smoking or the use of nicotine/nicotine-containing products for at least approximately 3 months

• Is in generally good health

Exclusion Criteria:

• Has a history of clinically significant abnormalities or diseases

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

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

• Has any personal or family history of a bleeding or a clotting disorder

• Has a history of frequent nose bleeds or has recurrent or active gingivitis

• Has a history of cancer

• Has a history of clinically significant cardiac disease

• Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies approximately 2 weeks prior to the administration of study drug

• Consumes excessive amounts of alcohol

• Consumes excessive amounts of caffeinated beverages per day

• Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of study

• Has a history of significant multiple and/or severe allergies (including latex) to prescription or non-prescription drugs or food

• Is currently a regular user of any illicit drugs or has a history of drug abuse within approximately 1 year