A Study to Evaluate the Relative Bioavailability and Effect of Food on Two Formulations of the MK-3682A Fixed-Dose Combination Tablets (MK-3682/MK-5172/MK-8742, 300 mg/ 100 mg/50 mg) in Healthy Adult Subjects.

Completed

• Conditions: HCV; Hepatitis C virus; 10047438

• Registration Number: NL-OMON41736
• Lead Sponsor: Merck Sharp & Dohme (MSD)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

1. Non-tobacco using males and non-pregnant females, 18-55 years of age, inclusive.
2. A body mass index (BMI) of 19-32 kg/m² inclusive.
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 likely to become pregnant during the study.
2. Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders.
3. 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>Hypotheses for this study:<br /><br><br /><br>- to estimate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax,<br /><br>C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites<br /><br>(IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two<br /><br>premarket formulations of a fixed-dose combination of MK-3682A (FDC-A and<br /><br>FDC-B) 300 mg/100 mg/50 mg relative to the individual components when<br /><br>co-administered at a dose of 300 mg/100 mg/50 mg.<br /><br><br /><br>- to estimate the effects of a high fat meal on the pharmacokinetic (PK)<br /><br>parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682<br /><br>and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742<br /><br>following administration of two premarket formulations of a fixed-dose<br /><br>combination of MK-3682A (FDC-A and FDC-B) 300 mg/100 mg/50 mg relative to the<br /><br>fasted state.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety </p><br>