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

• Status: Completed
• Trial end date: 2016-08-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Uprifosbuvir

Criteria

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

• Has had no clinically significant change in renal status at least 1 month prior to dosing and is not currently or has not previously been on hemodialysis

• Moderate RI: has baseline eGFR ≥ 30 mL/min/1.73m^2 and < 60 mL/min/1.73m^2, based on the Modification of Diet in Renal Disease (MDRD) equation at screening

• Severe RI: has baseline eGFR ≥ 15 mL/min/1.73m^2 and < 30 mL/min/1.73m^2, based on the MDRD equation at screening

Healthy Participants:

• Is within ± 10 years of the mean age of moderate and severe RI arms

• BMI is within 10% of the mean BMI of participants with moderate and severe RI arms

• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the Investigator

• Baseline CLcr ≥ 80 mL/min based on Cockcroft-Gault equation at screening

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