Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: MK-3402
Intervention description: MK-3402 administered as a single dose of 100 mg IV infusion on the following dosage days:
Panels A to D: Day 1 Panel E: Day 1 in Periods 1 and 2
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: MK-3402

Summary:

      The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402
      in participants with impaired renal function and healthy control participants, to investigate
      the extent to which MK-3402 is removed from the plasma by hemodialysis (HD), and evaluate the
      safety and tolerability of MK-3402 in participants with impaired renal function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is in good health based on medical history, physical examination, vital signs (VS)
             measurements, and electrocardiogram (ECG)s performed before randomization.

          -  Is in good health based on laboratory safety tests obtained at the screening visit and
             before administration of the initial dose of study drug.

          -  Has a body mass index (BMI) ≥18 kg/m2 and ≤40 kg/m2. BMI = weight (kg)/height (m)2.

          -  Male participants are eligible to participate if they agree to the following during
             the intervention period and for at least 90 days after the last dose of study
             intervention:

               -  Refrain from donating sperm

               -  Be abstinent from heterosexual intercourse as their preferred and usual lifestyle
                  (abstinent on a long-term and persistent basis) and agree to remain abstinent or
                  must agree to use contraception unless confirmed to be azoospermic (vasectomized
                  or secondary to medical cause)

          -  A female participant is eligible to participate if she is a woman of non-childbearing
             potential.

          -  Panel A: Has a baseline estimated glomerular filtration rate (eGFR) ≥60 and <90
             mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation.

          -  Panel B: Has a baseline eGFR ≥30 and <60 mL/min/1.73 m2 based on the MDRD equation.

          -  Panel C: Has a baseline eGFR ≥15 and <30 mL/min/1.73 m2 based on the MDRD equation.

          -  Panels A, B and C: Has had no clinically significant change in renal status at least 1
             month prior to dosing and is not currently receiving or has not previously been on
             hemodialysis (HD).

          -  Panel D: Has an eGFR ≥90 mL/min/1.73 m2 based on the MDRD equation.

          -  Panel E: Has end stage renal disease (ESRD) and maintained on a stable regimen of at
             least 3 times per week HD for at least 3 months prior to first dosing.

        Exclusion Criteria:

          -  Panels A, B, C and E: Has a history of any clinically significant concomitant disease
             or condition (including treatment for such conditions) or diseases whose current
             condition is considered clinically unstable that, in the opinion of the investigator,
             could either interfere with the study drug, compromise interpretation of study data,
             or pose an unacceptable risk to the patient.

          -  Panel D: Has a history of clinically significant endocrine, gastrointestinal (GI),
             cardiovascular, hematological, hepatic, immunological, renal, respiratory,
             genitourinary, or major neurological (including stroke and chronic seizures)
             abnormalities or diseases. Participants with a remote history of uncomplicated medical
             events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no
             recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at
             the discretion of the investigator.

          -  Is mentally or legally incapacitated, has significant emotional problems at the time
             of prestudy (screening) visit or expected during the conduct of the study or has a
             history of clinically significant psychiatric disorder that would impact study
             conduct. Participants who have had situational depression may be enrolled in the study
             at the discretion of the investigator.

          -  Has a history of cancer (malignancy).

               -  Exceptions: (1) Adequately treated nonmelanomatous skin carcinoma or carcinoma in
                  situ of the cervix or; (2) Other malignancies that have been successfully treated
                  with appropriate follow up and therefore unlikely to recur for the duration of
                  the study, in the opinion of the investigator and with agreement of the Sponsor
                  (eg, malignancies that have been successfully treated ≥10 years prior to the
                  prestudy screening visit).

          -  Has a history of significant multiple and/or severe allergies (eg, food, drug, latex
             allergy), or has had an anaphylactic reaction or significant intolerability (ie,
             systemic allergic reaction) to prescription or nonprescription drugs or food.

          -  Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human
             immunodeficiency virus (HIV).

          -  Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4
             weeks prior to the prestudy (screening) visit.

          -  Panels A, B, C and E: Is unable to refrain from or anticipates the use of any
             medication, including prescription and nonprescription drugs or herbal remedies for
             the prohibited time period.

          -  Panel D: Is unable to refrain from or anticipates the use of any medication, including
             prescription and nonprescription drugs or herbal remedies beginning approximately 2
             weeks (or 5 half-lives) prior to administration of the initial dose of study drug,
             throughout the study (including washout intervals between treatment periods), until
             the poststudy visit. There may be certain medications that are permitted.

          -  Has participated in another investigational study within 4 weeks (or 5 half-lives,
             whichever is greater) prior to study drug administration. The window will be derived
             from the date of the last dose of study medication in the previous study.