CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Ruzasvirdrug
Likely dose
Ruzasvir 60 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/NCT02076100
NCT02076100Phase 1Completed
CompareCT.gov

A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-8408 in Subjects With Hepatitis C Infection

Merck Sharp & Dohme LLC·interventional·Posted Mar 3, 2014·Updated Dec 24, 2018

In Brief

A Phase 1 clinical trial evaluating Ruzasvir for Hepatitis C Infection. Completed, enrolled 22 participants.

Detailed Summary

This is a 3-part study of Ruzasvir (MK-8408) for participants with hepatitis C infection. Successive participants will be enrolled as dose levels are evaluated to find the maximum safe and well tolerated dose of Ruzasvir. Part I will be for participants with hepatitis C virus (HCV) genotype 3 (GT3) and will run first: Part II will be for participants with HCV genotype 1a (GT1a), and Part III will be for participants with HCV genotype 2b (GT2b). Parts II and III may run concurrently. The primary study hypothesis is that a safe and tolerable dose of Ruzasvir that reduces viral load will be found to support further clinical investigation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Infection
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 3, 2014
Enrollment StartMar 27, 2014
Primary CompletionNov 15, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.3 years ago

Interventions

Ruzasvirdrug

Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.