A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)

Merck Sharp & Dohme LLC20 enrolled

Overview

This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

IDX320DRUG

IDX320 400 mg in tablets (8x50 mg) administered orally once daily

IDX184DRUG

IDX184 100 mg in capsules (2x50 mg) administered orally once daily

IDX184 placeboDRUG

IDX184 matching placebo in capsules administered orally once daily

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: To participate in the study, participants must meet the following requirements: 1. Must be a healthy male or female between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m2. 2. Must be a non-smoker. 3. Must agree to use an acceptable double-barrier method of birth control. 4. Must provide written informed consent after the study has been fully explained. Exclusion Criteria: Participants are not eligible if they meet any of the following: 1. Pregnant or breastfeeding. 2. History of clinically significant diseases, as determined by the investigator. 3. Safety laboratory abnormalities at screening which are clinically significant. 4. Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV). 5. 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. 6. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.