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, providing doses of 450 mg/ 100 mg/ 50 mg) in Healthy Adult Subjects

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, providing doses of 450 mg/ 100 mg/ 50 mg) in Healthy Adult Subjects - MK-3682A/PN019

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57828

Enrollment

Registered

2014-12-01

Start date

2014-12-08

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Hepatitis C virus

Interventions

Treatment A: Co-administration of 3 x 150 mg MK-3682 tablets, 1 x 100 mg MK-5172 tablet, and 1 x 50 mg MK-8742 tablet administered following an overnight fast of at least 10.5 hours. Treatment B:

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1. Females who are pregnant, lactating or likely tobecome pregnant during the study. 2. History of liver disease 3. Receipt of any drug as part of a research study within 30 days before initial dosing

Design outcomes

Primary

Measure	Time frame
Hypotheses: - To estimate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two premarket formulations of a fixed-dose combination ofMK-3682A (FDC-C and FDC-D) dosed at 450 mg/100 mg/50 mg relative to the individual components when co-administered at a dose of 450 mg/100 mg/50 mg. - To estimate the effects of a high fat meal on the pharmacokinetic(PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two premarket formulations of a fixed-dose combination of MK-3682A (FDC-C and FDC-D) dosed at 450 mg/100 mg/50 mg relative to the fasted state.	—

Measure

Time frame

Hypotheses: - To estimate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two premarket formulations of a fixed-dose combination ofMK-3682A (FDC-C and FDC-D) dosed at 450 mg/100 mg/50 mg relative to the individual components when co-administered at a dose of 450 mg/100 mg/50 mg. - To estimate the effects of a high fat meal on the pharmacokinetic(PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two premarket formulations of a fixed-dose combination of MK-3682A (FDC-C and FDC-D) dosed at 450 mg/100 mg/50 mg relative to the fasted state.

—

Secondary

Measure	Time frame
Safety parameters	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)