Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Intervention: MK-0822
Intervention description: A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50
      milligram (mg) dose of MK-0822 in participants with and without moderate hepatic
      insufficiency (abnormal liver function) in order to determine to what degree hepatic
      dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that
      plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to
      that in matched healthy participants following a single 50 mg oral dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Not currently pregnant, nursing or planning to be pregnant through-out the course of
             the study; agree to use specified contraception per protocol requirement

          -  Body Mass Index (BMI) of ≤ 39 kg/m^2 (not obese)

          -  Judged to be in good health (for healthy participant population)

          -  Non-smoker for the past 6-months; social smokers (smoke less than 10 cigarettes within
             the past 3 months; or per discretion of the study Investigator, quit smoking within
             the past 3 months.

          -  Diagnosed with chronic (more than 6 months), stable (no acute episodes of illness
             within the previous 2 months) hepatic insufficiency (liver dysfunction) with features
             of cirrhosis due to any cause (for the moderate hepatic insufficiency participant
             population)

          -  Possess the ability to understand the study, grant voluntary informed consent and
             willingly comply with all study requirements

        Exclusion Criteria:

          -  Does not meet the age requirement, is mentally or legally incapacitated, has or is
             expected to have significant emotional problems, or a history of a clinically
             significant psychiatric disorder

          -  Has been diagnosed with a disease or medical condition which may pose a risk to the
             participant or may confound the study results

          -  Compromised renal (kidney) function, significant organ system disease(s) or cancer(s)

          -  Unable to refrain from or anticipates the use of any new medication, including
             prescription and non-prescription drugs or herbal remedies

          -  Meets the requirements of the study in regard to current medication profile including:
             prescribed medications, caffeine, alcohol, over-the-counter drugs, herbals and
             nutritional products; with expected non-use of recreational (illicit) drugs associated
             with misuse, abuse and/or addiction

          -  Had surgery, donated 1 unit of blood or received another investigational study
             medication within 4 weeks prior to the study's first dose of investigational product

          -  History of multiple and/or severe allergies, or has had a life-threatening reaction or
             inability to tolerate prescription or non-prescription drugs or food