A Study of Single Dose MK-3614 (MK-3614-001)(COMPLETED)

NCT ID: NCT01104545

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-01
• Study Completion Date: 2009-05-01

Brief Summary

This study will determine if MK-3614, given as single doses, is safe and well tolerated in healthy males and male participants with mild to moderate hypertension.

Detailed Description

Up to three planned panels of either 8 healthy participants (Panels A and B) or 8 participants with mild to moderate hypertension (Panel C) will be enrolled. In Panels A and B, 8 participants will alternately receive single rising doses of MK-3614 or placebo. All doses will be administered in the fasted state, except Panel A, Period 3 in which a standard high-fat breakfast provided approximately 30 minutes prior to dosing. Panel A will begin first. At least 3 days will elapse before participants in the alternate panel (Panel B) will receive the next higher dose. In Panel C, 8 mild to moderate hypertensive male participants will receive single rising doses of MK-8892 or placebo. For all panels, there will be at least 7 days washout between treatment periods for any given participant. Participants may only be enrolled in one panel of the study. All participants in periods of all panels (with exception of 0.25 mg fasted/fed periods) will be randomly assigned to either study drug or placebo, i.e., a participant could be assigned to receive study drug in one period and placebo in another. As per the protocol allocation plan, the same participants will receive 0.25 mg MK-3612 in a fasted and fed state.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Panel A - Healthy

Healthy participants receive single oral dose of MK-3614 0.25 mg, 1.25 mg, 0.25 mg w/ food, 0.75 mg or matching placebo. There is at least a 7-day washout between the 4 dosing periods. All doses were administered after an 8-hour fast except for Period 3. Period 3 dose was administered after the ingestion of a high-fat breakfast.

Group Type: EXPERIMENTAL

MK-3614

Intervention Type: DRUG

Comparator: Placebo

Intervention Type: DRUG

Panel B - Healthy

Healthy participants receive single oral dose of MK-3614 0.5 mg. 0.75 mg, 0.25 mg twice a day (b.i.d.), 0.25 mg three times a day (t.i.d), or matching placebo. There is at least a 7-day washout between the 4 dosing periods. All doses were administered after an 8-hour fast

Group Type: EXPERIMENTAL

MK-3614

Intervention Type: DRUG

Comparator: Placebo

Intervention Type: DRUG

Panel C - Hypertensive

Hypertensive participants receive single oral dose of MK-3614 0.75 mg. 0.5 mg. 0.75 mg, 0.75 mg or matching placebo. There is at least a 7-day washout between the 4 dosing period. All doses were administered after an 8-hour fast

Group Type: EXPERIMENTAL

MK-3614

Intervention Type: DRUG

Comparator: Placebo

Intervention Type: DRUG

Interventions

MK-3614

Intervention Type: DRUG

Comparator: Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy participants between 18 to 45 years of age; otherwise healthy participants between 18 to 55 years of age newly diagnosed with grade 1 or 2 hypertension
• Participant is in good general health
• Participant is a nonsmoker

Exclusion Criteria

• Participant has a history of stroke, seizure or major neurological disease
• Participant has functional disability that can interfere with rising from a sitting position to a standing position
• Participant has a family history of a bleeding or clotting disorder
• Participant has a history of cancer
• Participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
• Participant consumes excessive amounts of alcohol or caffeine
• Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK-3614-001

Identifier Type: OTHER

Identifier Source: secondary_id

2010_525

Identifier Type: -

Identifier Source: secondary_id

3614-001

Identifier Type: -

Identifier Source: org_study_id