A Study to Evaluate the Comparative Bioavailability of Formulation Batches of MK-3682A Fixed-Dose Combination Tablet (MK-3682/MK-5172/MK-8742, 225 mg/50 mg/25 mg) in Healthy Adult Subjects

Completed

Conditions: HCV
Hepatitis C virus
10047438

Registration Number: NL-OMON42602

Lead Sponsor: Merck Sharp & Dohme (MSD)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

1. Non-tobacco using males and females, 18-55 years of age, inclusive.
2. A body mass index (BMI) of 19-32 kg/m² inclusive as calculated according to QPS Netherlands B.V. Standard Operating Procedures.
3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.

Exclusion Criteria

1. Females who are pregnant, lactating or intend to become pregnant during the study.
2. History of allergy or sensitivity to MK-3682, MK-5172, or MK-8742 or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the integrity of study.
3. Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension), stroke, renal or hepatic disorder, diabetes or bleeding
4. Receipt of any drug as part of a research study within 30 days before initial dosing.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Hypothesis (Estimation):<br /><br><br /><br>To estimate the comparative bioavailability of each of the three test PMFs of<br /><br>an FDC of MK-3682A (FDC-F, FDC-G, and FDC-H) relative to the reference PMF of<br /><br>MK-3682A FDC (FDC-E) following single-dose administration.</p><br>

Secondary Outcome Measures