Single and Multiple Dose Study of Uprifosbuvir (MK-3682/IDX21437) in Healthy and Hepatitis C Virus (HCV)-Infected Participants (MK-3682-001)

• Status: Completed
• Trial end date: 2015-09-11
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK) of uprifosbuvir (MK-3682/IDX21437) in healthy participants and in participants infected with Hepatitis C virus (HCV) genotype (GT)1-GT6. The effect of food on the PK of uprifosbuvir will be evaluated. The antiviral activity of uprifosbuvir will also be assessed in HCV-infected participants.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Hydroxyitraconazole; Itraconazole; Uprifosbuvir

Criteria

Inclusion Criteria:

All Participants:

• of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug

• must not have consumed grapefruit or grapefruit juice within 7 days of Day -1 and throughout the study

HCV Participants:

• documented clinical history compatible with chronic hepatitis C.

• have not received direct-acting antiviral treatment for hepatitis C infection

• has HCV Genotype 1, 2, 3, 4, 5 or 6

Exclusion Criteria:

All Participants:

• pregnant or breastfeeding

• co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).

• decompensated liver disease

• other clinically significant medical conditions or laboratory abnormalities.