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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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.