The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
Chronic Hepatitis C, Renal Impairment
About this trial
This is an interventional treatment trial for Chronic Hepatitis C
Eligibility Criteria
Inclusion Criteria:
All Participants
- For a female of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method. Females of non-childbearing potential must have undergone a sterilization procedure at least 6 months prior to the first dose
- Non-vasectomized male participants must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 90 days after stopping the study medication and agree not to donate sperm during this time period Participants with ESRD on HD
- Maintained on a stable regimen of HD within 3 months prior to first dosing Participants with Severe Renal Impairment
- Estimated glomerular filtration rate (eGFR) at screening is < 30 mL/min/1.73m^2 Healthy Controls
- Participant is within ± 10 years of the mean age and within 10% of the mean body mass index of severe renal impairment participants
- eGFR at screening is >=80 mL/min/1.73m^2
Exclusion Criteria:
All Participants
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease whose current condition is considered unstable
- History or presence of alcoholism and drug abuse within the past 6 months
- Female participants who are pregnant or lactating
- Regular user of any medication (including over the counter) that would significantly alter GFR
- Donation of blood or significant blood loss within 56 days prior to the first dose of study medication(s)
- Plasma donation within 7 days prior to the first dose of study medication(s)
- A renal transplant or nephrectomy Participants with ESRD or Severe Renal Impairment
- Rapidly fluctuating renal function
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Participants with End Stage Renal Disease on Hemodialysis
Participants with Severe Renal Impairment
Healthy Participants
Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days..
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.