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Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030) | Clinical Trials | Clareo Health

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Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030)

A Two-Part, Open-Label Study to Investigate the Single-Dose Pharmacokinetics of MK-3682B (MK-3682/MK-5172/MK-8408 Fixed Dose Combination) When Administered to Subjects With Moderate and Severe Renal Insufficiency

NCT02661126•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the plasma pharmacokinetics (PK) of single doses of MK-3682B, a fixed dose combination (FDC) tablet containing uprifosbuvir (MK-3682) + grazoprevir (MK-5172) + ruzasvir (MK-8408) in participants with moderate (Part 1) and severe (Part 2) renal insufficiency (RI) to plasma PK in healthy participants.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•All Participants:
•Healthy adult males or females 18-80 years of age at screening
•Continuous non-smokers or moderate smokers (≤ 20 cigarettes/day or the equivalent) and agrees to consume no more than 10 cigarettes per day during the study period
•BMI ≥ 18 and ≤ 40.0 kg/m\^2
•Agrees not to become pregnant or father a child during participation in the study
•Females of childbearing potential must either be abstinent for 14 days prior to dosing and throughout the study or be using an acceptable birth control method
•Vasectomized or non-vasectomized males must agree to use a condom with spermicide or abstain from sexual intercourse from the first dose until 90 days after dosing
•Males must agree not to donate sperm from dosing until 90 days after dosing
•Moderate and Severe RI Participants:
•Baseline health is judged to be stable based on medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the Investigator
+8 more criteria

Exclusion Criteria

•Is mentally or legally incapacitated or has significant emotional problems at the time of the screening
•History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator
•History of any illness that, in the opinion of the Investigator, might confound the results of the study or poses an additional risk by participating in the study
•Is female and pregnant or lactating
•Positive results for the urine or saliva drug screen or urine or breath alcohol screen at screening or check-in unless the positive drug screen is due to prescription drug use that is approved by the Investigator and Sponsor
•Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
•Seated heart rate is equal to or lower than 44 beats per minute (bpm) or higher than 100 bpm at screening
•Has had a renal transplant or has had nephrectomy
•Donation of blood or had significant blood loss within 56 days prior to dosing of study drug, or donation of plasma within 7 days prior to dosing
•Has participated in another clinical trial within 28 days prior to dosing of study drug

Key Dates

Start Date

January 19, 2016

Primary Completion Date

August 26, 2016

Completion Date

August 26, 2016

Last Updated

January 9, 2019

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

MK-3682B

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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: January 9, 2019Data 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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Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030)

Inclusion Criteria

Exclusion Criteria

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