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.

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. - MK-3682A/PN018

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41736

Enrollment

Registered

2014-12-01

Start date

2014-12-08

Completion date

Unknown

Last updated

2024-04-23

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 2 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: 1

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 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.

Design outcomes

Primary

Measure	Time frame
Hypotheses for this study: - 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 of MK-3682A (FDC-A and FDC-B) 300 mg/100 mg/50 mg relative to the individual components when co-administered at a dose of 300 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-A and FDC-B) 300 mg/100 mg/50 mg relative to the fasted state.	—

Measure

Time frame

Hypotheses for this study: - 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 of MK-3682A (FDC-A and FDC-B) 300 mg/100 mg/50 mg relative to the individual components when co-administered at a dose of 300 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-A and FDC-B) 300 mg/100 mg/50 mg relative to the fasted state.

—

Secondary

Measure	Time frame
Safety	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)