Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172-013)
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatic Insufficiency; Liver Failure
Intervention: Grazoprevir
Intervention description: Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily 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: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare the pharmacokinetics (PK) of grazoprevir (MK-5172) when administered
      to participants with mild, moderate or severe hepatic insufficiency (assessed by the criteria
      of the Child-Pugh's scale) with the PK of grazoprevir when administered to healthy
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  If female, must be of non-childbearing potential or willing to use at least 2
             acceptable methods of contraception from enrollment to 2 weeks after the last dose of
             study drug

          -  No clinically significant abnormality on electrocardiogram

        Hepatic Insufficiency Participants Only:

          -  Other than hepatic insufficiency with features of cirrhosis, is otherwise in good
             health based on medical history, physical examination, vital signs, and laboratory
             safety tests

          -  Chronic (>6 months), stable (no acute episodes of illness within the previous 2 months
             due to deterioration in hepatic function) hepatic insufficiency with features of
             cirrhosis due to any etiology

          -  Score on the Child-Pugh scale must range from 5 to 6 (mild hepatic insufficiency) to
             from 7 to 9 (moderate hepatic insufficiency) to from 10 to 15 (severe hepatic
             insufficiency)

        Matched Healthy Participants Only:

        - In good health based on medical history, physical examination, vital signs, and
        laboratory safety tests

        Exclusion Criteria:

          -  History of any illness that might confound the results of the study or poses an
             additional risk to the participant

          -  History of clinically significant endocrine, gastrointestinal (other than related to
             their hepatic impairment), cardiovascular, hematological, immunological, renal,
             respiratory, or genitourinary abnormalities or diseases

          -  Pregnancy

          -  Estimated creatinine clearance of ≤60 mL/min

          -  History of stroke, chronic seizures, or major neurological disorder

          -  History of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or
             myeloproliferative disease, regardless of the time since treatment

          -  Unable to refrain from or anticipates the use of any medication, including
             prescription and non-prescription drugs or herbal remedies (such as St. John's Wort,
             green tea, gingko, coenzyme Q, ginseng, echinacea, etc.) or nutritional supplements
             (e.g., garlic supplements), beginning approximately 2 weeks (or 5 half-lives) prior to
             administration of the initial dose of study drug, throughout the study, until the
             poststudy visit

          -  Participated in another investigational study within 4 weeks

          -  History of significant multiple and/or severe allergies or has had an anaphylactic
             reaction or significant intolerability to prescription or non-prescription drugs or
             food

        Hepatic Insufficiency Participants Only:

        - Has a history of hepatitis C infection by serology, regardless of most recent viral load
        status.

        Matched Healthy Participants Only:

          -  History of any chronic and/or active hepatic disease including elevations of serum
             transaminases, hepatitis, biliary tract disease, or a history of any significant
             gastrointestinal surgery.

          -  History of hepatitis C. Participants with a history of self-limited hepatitis A with
             complete resolution documented at least 6 months prior to entry will be eligible for
             inclusion