CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 178 enrolled
Drug / intervention
Uprifosbuvir +2 moredrug
Likely dose
Uprifosbuvir 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01974687
NCT01974687Phase 2Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Nov 1, 2013·Updated Sep 13, 2018

In Brief

A Phase 2 clinical trial evaluating Uprifosbuvir, Placebo, and 1 other intervention for Chronic Hepatitis C. Completed, enrolled 178 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 1, 2013
Enrollment StartOct 31, 2013
Primary CompletionSep 2, 2015
Study CompletionSep 11, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.7 years ago

Interventions

Uprifosbuvirdrug

Uprifosbuvir 5 mg, 25 mg, or 50 mg capsule, or 150 mg tablet, administered by mouth.

Placebodrug

Matching placebo to uprifosbuvir capsule administered by mouth.

Itraconazoledrug

Itraconazole is supplied as 10 mg/mL oral solution or 100 mg capsules administered by mouth.