pharmacokinetics of mk-3682b in participants with moderate to severe renal insufficiency (mk-3682b-030)

Conditions: Hepatitis C

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 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