Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: MK-3866
Intervention description: Single IV infusion of 200 mg administered over 30 minutes (±5 minutes) on Day 1 of each treatment period.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between
      participants with impaired renal function and healthy control participants, to investigate
      the extent to which MK-3866 is removed from the plasma by hemodialysis (HD), and evaluate the
      safety and tolerability of MK-3866 in participants with impaired renal function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of non-childbearing potential. Male participants with female partner(s) of
             child-bearing potential agree to use a medically acceptable method of contraception
             during the study and for 90 days after dosing. If partner is pregnant, males agree to
             use a condom; if partner is of child-bearing potential, partner must use additional
             birth control

          -  Male participants agree not to donate sperm from the first dose until 90 days after
             dosing

          -  Adequate venous access

        Renal Impaired Participants

          -  Liver function tests (serum alanine aminotransferase [ALT] and aspartate
             aminotransferase [AST]) and serum bilirubin (total and direct) within upper limit of
             normal

          -  Panels A, B, and C: no clinically significant change in renal status at least 1 month
             prior to dosing and not currently or previously been on hemodialysis

          -  Panel E only: ESRD maintained on stable regimen of at least 3 times per week HD for at
             least 3 months prior to first dosing

        Healthy Participants

          -  Age within ± 15 years of the mean age of participants with impaired renal function to
             which the healthy participant is matched

          -  Medically healthy as per medical history, physical examination, vital signs, 12-lead
             electrocardiograms (ECGs), and clinical laboratory safety tests

          -  Blood urea nitrogen, liver function tests (ALT, AST, alkaline phosphatase [ALP]), and
             serum bilirubin (total and direct) within upper limit of normal.

        Exclusion Criteria:

          -  Mentally/legally incapacitated, or significant emotional problems or significant
             psychiatric disorder

          -  History of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, respiratory, genitourinary or major
             neurological abnormalities or diseases

          -  History of any illness that might confound the results of the study or poses an
             additional risk to the participant by their participation in the study

          -  Clinically significant history of cancer

          -  Smoker and/or has used nicotine or nicotine-containing products within 3 months prior
             to screening

          -  Female participants of childbearing potential, pregnant, or lactating

          -  Positive results for urine or saliva drug screen and/or urine or breath alcohol screen
             at screening or check-in

          -  Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg), or hepatitis C virus (HCV)

          -  Consumes more than 3 glasses of alcoholic beverages within 6 months of screening

          -  Consumes excessive amounts of coffee, tea, cola, energy-drinks, or other caffeinated
             beverages per day

          -  Major surgery, donated or lost 1 unit of blood within 4 weeks prior to screening, or
             donated plasma within 7 days prior to dosing in Part 1 or first dose in Part 2

        Renal Impaired Participants

          -  Panels A, B, and C: Failed renal transplant or has had nephrectomy

          -  Panels A, B, and C: Rapidly fluctuating renal function, as determined by historical
             measurements; or demonstrated/suspected renal artery stenosis

          -  Panel E only: Has required frequent emergent HD (≥3) within a year prior to first
             dosing

        Healthy Participants

          -  Renal transplant or nephrectomy