The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
Condition: Chronic Hepatitis C; Renal Impairment
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Renal Insufficiency
Intervention: Grazoprevir; Elbasvir
Intervention description: 100 mg oral tablet administered once a day for 10 days; 50 mg oral tablet administered once a day for 10 days
Intervention MeSH terms: Grazoprevir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of
      combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic
      (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with
      end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal
      impairment. Both groups were compared to healthy matched controls.
    

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