NCT02666352

A Study of the Pharmacokinetics of Uprifosbuvir (MK-3682) and Ruzasvir (MK-8408) in Participants With Moderate and Severe Hepatic Insufficiency (MK-3682-029)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Uprifosbuvir	A single dose of uprifosbuvir 450 mg (given as three 150-mg tablets) taken by mouth.
DRUG	Ruzasvir	A single dose of ruzasvir 60 mg (given as six 10-mg capsules) taken by mouth.

Timeline

• Start date: 2016-01-22
• Primary completion: 2017-01-16
• Completion: 2017-01-16
• First posted: 2016-01-28
• Last updated: 2018-09-17
• Results posted: 2018-09-17