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

A Phase I/IIa Study Assessing Single and Multiple Doses of IDX21437 in Healthy and HCV-Infected Subjects

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.

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.