A Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006)

Merck Sharp & Dohme LLC12 enrolled

Overview

The purpose of this study is to: * Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and tablet prototype test formulation) * Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting. * Determine the amount of study drug that is in the blood after eating a meal. * Evaluate the safety of the tablet form of samatasvir in healthy people.

Each participant will receive each of the formulations in a crossover design. Part A Periods 1 and 2: Participants will receive either samatasvir capsules or tablets according to randomization under fasting conditions on Days 1 and 8. Part A Period 3: All participants will receive samatasvir tablets under fed conditons on Day 15. Each dose will be separated by a 7-day wash-out period. Part B: All participants will receive samatasvir capsules under fed conditons on Day 1.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

Samatasvir tabletDRUG

Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)

Samatasvir capsuleDRUG

Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)

Eligibility

Sex: MALEMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Must be a healthy male with body mass index (BMI) between 18 and 35 kg/m * Must agree to use an acceptable double-barrier method of birth control. * Must provide written informed consent after the study has been fully explained. Exclusion Criteria: * History of clinically significant diseases, as determined by the investigator. * Safety laboratory abnormalities at screening which are clinically significant. * Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV). * Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study. * Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.