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

COMPLETEDPHASE1

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

NCT02666352•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•HI Participants Only:
•Has a diagnosis of chronic (\>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) HI features of cirrhosis;
•Part 1 only: Participant's score on the Child-Pugh scale ranges from 7 to 9 (moderate HI) at study start.
•Part 2 only: Participant's score on the Child-Pugh scale ranges from 10 to 15 (severe HI) at study start.
•All Participants:
•Body mass index (BMI) ≥19 and ≤ 40 kg/m\^2;
•Continuous non-smokers or moderate smokers (of fewer than 20 cigarettes/day or the equivalent). Participants must agree to consume no more than 10 cigarettes or equivalent/day from the time of screening and throughout the period of sample collection;
•Health is judged to be stable based on medical history (except for the hepatic impairment condition), physical examination, vital signs, electrocardiogram (ECGs), and laboratory safety tests;
•For female participants of childbearing potential: either sexually inactive for 14 days prior to study start and throughout study or be using an acceptable birth control method;
•Female participants who are sexually inactive, but become sexually active during the course of the study must agree to use a double physical barrier method (e.g., condom and diaphragm) and a chemical barrier (e.g., spermicide) from the time of the start of sexual activity through completion of the study;
+3 more criteria

Exclusion Criteria

•HI Participants Only:
•Presence of moderate or severe renal insufficiency (estimated glomerular filtration rate \[eGFR\] ≤50 mL/min/1.73 m\^2 calculated according to the Modification of Diet in Renal Disease \[MDRD\] study equation);
•Presence of drug abuse within the past 6 months prior to dosing.
•Healthy Participants Only:
•Presence of moderate or severe renal insufficiency (eGFR ≤60 mL/min/1.73 m\^2 calculated according to the MDRD study equation);
•History or presence of alcoholism or drug abuse within the past 2 years prior to dosing;
•All Participants:
•Is mentally or legally incapacitated or has significant emotional problems at the time of study start or expected during the study;
•History or presence of clinically significant medical or psychiatric condition or disease;
•History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds;
+7 more criteria

Key Dates

Start Date

January 22, 2016

Primary Completion Date

January 16, 2017

Completion Date

January 16, 2017

Last Updated

September 17, 2018

Enrollment

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

Uprifosbuvir

DRUG

Ruzasvir

DRUG

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Carcinoma, HepatocellularHepatitis C, Chronic+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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