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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

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 - MK-3682A/PN022 (MK-3682/MK-5172/MK-8742, 225mg/50mg/25mg)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42602
Enrollment
16
Registered
2015-06-01
Start date
2015-06-14
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

The subjects will receive the study drugs, under direct observation, on Day 1 of each period according to the four-treatment, four-period, four-sequence randomization schedule. Each treatment will be

Sponsors

Merck Sharp & Dohme (MSD)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Hypothesis (Estimation): To estimate the comparative bioavailability of each of the three test PMFs of an FDC of MK-3682A (FDC-F, FDC-G, and FDC-H) relative to the reference PMF of MK-3682A FDC (FDC-E) following single-dose administration.

Secondary

MeasureTime frame
Safety

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)