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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Drug: IDX719; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01508156

1894-001

IDX-06A-001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Group A: Healthy Participants

Experimental group

Description:

Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses.

Treatment:

Drug: IDX719

Drug: Placebo

Group B: HCV Participants

Experimental group

Description:

Treatment-naive participants infected with HCV genotype (GT) 1, GT2, or GT3 take IDX719 (1 mg - 100 mg) or matching placebo as either 1 single dose or as 7 daily doses.

Treatment:

Drug: IDX719

Drug: Placebo