study to investigate the influence of hepatic insufficiency on the pharmacokinetics of grazoprevir (mk-5172-013)

Conditions: Hepatitis C

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