Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001)
Condition: Healthy Volunteers; Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: MK-6183
Intervention description: MK-6183 (CB-238,614) is supplied as lyophilized powder 500 mg vial and mixed into solution for 100 mL intravenous (IV) administration over 1 hour.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to characterize the effect of renal function on the plasma,
      urine, and dialysate pharmacokinetic profile of MK-6183 (CB-238,618) in humans. The study
      will also assess the safety profile and tolerability of MK-6183 in healthy participants,
      participants with varying degrees of renal impairment (RI), or participants with end-stage
      renal disease (ESRD) requiring hemodialysis (HD), based on estimated glomerular filtration
      rate (eGFR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are healthy; or who have mild, moderate, or severe RI; or who have
             ESRD requiring HD. Participants with ESRD requiring HD should have been receiving HD 3
             times per week for at least 3 months preceding the initial dose in this study

        Exclusion Criteria:

          -  For healthy participants (Group A): history or presence of any clinically significant
             illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic,
             gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic,
             musculoskeletal, or psychiatric) or any other condition, including clinically
             significant anemia, which in the opinion of the investigator would jeopardize the
             safety of the participant or the validity of the study results

          -  For participants with RI (Groups B to E): as above, except that RI and other medical
             conditions commonly associated with renal impairment (eg, hypertension, diabetes,
             which should be stable for at least three months preceding the initial dose of study
             medication in this study) are allowed

          -  Clinically significant abnormalities on physical examination, medical history, 12-lead
             electrocardiogram (ECG), vital signs, or laboratory values, as judged by the
             investigator or designee. Subjects with renal impairment should have clinical
             laboratory values consistent with their disease and approved by the investigator

          -  Evidence of clinically significant hepatic impairment including alanine
             aminotransferase or aspartate aminotransferase >1.5 × upper limit of normal (ULN) or
             bilirubin >1 × ULN

          -  Hemoglobin <8 g/dL, unless considered stable and not clinically significant in the
             opinion of the investigator in subjects with ESRD and on HD

          -  Participants with renal impairment who are not on a chronic stable drug regimen,
             defined as starting a new drug or changing dosage within 14 days prior to
             administration of study medication, except for drugs administered in relationship to
             HD

          -  Participants with fluctuating or rapidly deteriorating renal function (assessment of
             the stability of the subject's renal function will be determined by the investigator)

          -  Participant has a currently functioning renal transplant and/or has been on
             significant immunosuppressant therapy, as determined by the investigator, within the
             last 6 months