CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Uprifosbuvir +1 moredrug
Likely dose
Uprifosbuvir 450 mg (single dose) and ruzasvir 60 mg (single dose), both oralAI-extracted
Key inclusion· 7
  • ✓Chronic (>6 months), stable hepatic insufficiency with cirrhosis features; no acute episodes within prior 2 months due to hepatic function deterioration.
  • ✓Part 1: Child-Pugh score 7-9 (moderate hepatic impairment).
  • ✓Part 2: Child-Pugh score 10-15 (severe hepatic impairment).
  • ✓BMI ≥19 and ≤40 kg/m².
Key exclusion· 10
  • ✕Moderate or severe renal insufficiency (eGFR ≤50 mL/min/1.73 m² for HI participants; ≤60 mL/min/1.73 m² for healthy participants).
  • ✕Drug abuse within past 6 months (HI participants) or past 2 years (healthy participants).
  • ✕History or presence of clinically significant medical or psychiatric condition or disease.
  • ✕History or presence of hypersensitivity or idiosyncratic reaction to study drugs or related compounds.

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

Search/NCT02666352
NCT02666352Phase 1Completed
CompareCT.gov

A Two-Part, Open-Label Study to Investigate the Single-Dose Pharmacokinetics of MK-3682 and MK-8408 When Coadministered to Subjects With Moderate and Severe Hepatic Insufficiency

Merck Sharp & Dohme LLC·interventional·Posted Jan 28, 2016·Updated Sep 17, 2018

In Brief

A Phase 1 clinical trial evaluating Uprifosbuvir and Ruzasvir for Hepatitis C, Chronic. Completed, enrolled 24 participants.

Detailed Summary

This is a non-randomized, open-label, single-dose study to evaluate the pharmacokinetics (PK) of uprifosbuvir (MK-3682), the M5 and M6 metabolites of uprifosbuvir, and ruzasvir (MK-8408), in participants with moderate hepatic insufficiency (HI), participants with severe HI, and age-matched healthy control participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 28, 2016
Enrollment StartJan 22, 2016
Primary CompletionJan 16, 2017
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 10.4 years ago

Interventions

Uprifosbuvirdrug

A single dose of uprifosbuvir 450 mg (given as three 150-mg tablets) taken by mouth.

Ruzasvirdrug

A single dose of ruzasvir 60 mg (given as six 10-mg capsules) taken by mouth.