Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)

Merck Sharp & Dohme LLC130 enrolled

Overview

The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

130

Conditions

Hepatitis C, Chronic

Interventions

IDX719DRUG

IDX719 liquid suspension (1 - 100 mg) taken by mouth.

PlaceboDRUG

Placebo liquid suspension matching IDX719 taken by mouth.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * All Participants * Is in good general health. * Agrees to use double-barrier method of birth control for at least 90 days after the last dose of study drugs. * HCV Participants * Has documented GT1, GT2, or GT3 chronic HCV infection. Exclusion Criteria: * All Participants * Is pregnant or breastfeeding. HCV Participants * Has received prior HCV treatment. * Is co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).

Outcomes

Primary Outcomes

Percentage of participants experiencing an adverse event (AE)

Time frame: Up to 14 days

Percentage of participants experiencing serious AEs (SAEs)

Time frame: Up to 14 days

Change in HCV ribonucleic acid (RNA)

Time frame: Baseline and Day 10

Maximum plasma drug concentration (Cmax)