Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
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: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib
      administered to participants with impaired renal/kidney function to those of a healthy
      matched control group. The primary hypothesis is that plasma AUC0-∞ of odanacatib in
      participants with impaired renal function 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; individual agrees to use specified contraception per protocol requirement
             for duration of study. Note: All females must have a serum pregnancy test to ensure
             and document negative test results prior to inclusion in the study.

          -  Body Mass Index (BMI) of up to 39.49kg/m^2

          -  Assessed to be in good health, including no clinically significant cardiac
             abnormalities based on results from an electrocardiogram (ECG) performed at
             pre-screening and/or prior to administration of study drug.

          -  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.

          -  Agrees to adhere to all smoking and dietary restrictions associated with the study.

          -  Possess the ability to understand the study, grant voluntary informed consent, and
             willingly comply with all study requirements.

        Inclusion Criterion Specific to Participants with Renal/Kidney Insufficiency:

          -  Creatinine clearance of <30 mL/min

        Inclusion Criterion Specific to Healthy Volunteers:

          -  Creatine clearance of ≥ 90 mL/min (for healthy volunteers)

        Exclusion Criteria:

          -  Does not meet the age requirement, is mentally or legally incapacitated, has or is
             expected to have significant emotional problems, and/or a history of a clinically
             significant psychiatric disorder.

          -  Diagnosed with a disease or medical condition which may pose a risk to the participant
             or may confound the study results.

          -  Has demonstrated or suspected stenosis (narrowing) of the renal artery, and/or has had
             a renal transplant and/or kidney removal.

          -  Has current, unstable, significant organ system disease(s) and/or cancer(s).

          -  Has had a surgical procedure, donated 1 unit of blood or received another
             investigational study medication within 4 weeks prior to the study's first dose of
             investigational product.

          -  Unable to refrain from or anticipates the use of any new medication, including
             prescription and non-prescription drugs and/or herbal remedies. Exceptions may include
             medications prescribed for prevention of disease or preservation of a healthy life.

          -  Uses any medication or agent that has the potential to significantly alter
             renal/kidney function.

          -  Unable to avoid taking diuretics (within 4 hours prior to and after dosing with the
             investigational product) or phosphate binders containing aluminum, calcium or
             lanthanum salts; iron supplements or other metal cations; antacids; or multivitamins
             containing iron or zinc (within 8 hours prior to dosing and 4 hours after dosing with
             the investigational product). Note: individuals prescribed to diuretics must be on a
             stable dose for at least 4 weeks prior to the study's start date in order to
             participate.

          -  History of multiple and/or severe allergies, has had a life-threatening reaction to a
             drug or other agent, and/or inability to tolerate prescription or nonprescription
             drugs and/or food.