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

Hepatitis C Clinical Trial

Official title: A Phase I, Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C

• NCT number: NCT01335607
• Study type: Interventional
• Source: Merck Sharp & Dohme Corp.
• Status: Completed
• Phase: Phase 1
• Start date: April 2011
• Completion date: May 2011