a study of the pharmacokinetics of uprifosbuvir (mk-3682) and ruzasvir (mk-8408) in participants with moderate and severe hepatic insufficiency (mk-3682-029)

Conditions: Hepatitis C, Chronic

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 criteria:
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; * vasectomized or non-vasectomized male participants must agree to use a condom with spermicide or abstain from sexual intercourse from dosing until 90 days after dosing; * male participants must agree not to donate sperm from dosing until 90 days after dosing; * able to swallow multiple tablets and capsules. 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; * female participants who are pregnant or lactating; * positive results at study start for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv); * unable to refrain from or anticipates the use of any medication or substance (including prescription or over-the-counter, vitamin supplements, natural or herbal supplements) for the prohibited time period; * has taken amiodarone at any time in their life; * donation of blood \>500 ml or had significant blood loss within 56 days prior to the dose of study drugs; * plasma donation within 7 days prior to the dose of study drugs; * dosed in another clinical trial within 28 days prior to dosing of study drugs;