NCT01974687

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Uprifosbuvir	Uprifosbuvir 5 mg, 25 mg, or 50 mg capsule, or 150 mg tablet, administered by mouth.
DRUG	Placebo	Matching placebo to uprifosbuvir capsule administered by mouth.
DRUG	Itraconazole	Itraconazole is supplied as 10 mg/mL oral solution or 100 mg capsules administered by mouth.

Timeline

• Start date: 2013-10-31
• Primary completion: 2015-09-02
• Completion: 2015-09-11
• First posted: 2013-11-01
• Last updated: 2018-09-13
• Results posted: 2018-09-13