Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)
Condition: Renal Insufficiency; Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: sugammadex
Intervention description: sugammadex 4 mg/kg IV bolus
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the plasma pharmacokinetics of a single 4 mg/kg
      intravenous (IV) dose of sugammadex in participants with moderate and severe renal
      insufficiency compared to that in participants with normal renal function. The study consists
      of two parts. In Part 1, participants with renal insufficiency and healthy participants will
      be administered study drug by IV bolus injection into a peripheral vein. In Part 2,
      participants with renal insufficiency and healthy participants will be administered study
      drug as an IV bolus into a peripheral vein, through an IV catheter connected to IV tubing
      with injection port. Subjects who participate in Part 1 of study may be enrolled in Part 2,
      which would reduce the overall number of participants enrolled for the study.
    

Eligibility criteria:

        Inclusion Criteria:

        All Participants:

          -  Body Mass Index ≥18 to ≤40 kg/m^2

          -  Females of childbearing potential must either be sexually inactive (abstinent) for 14
             days prior to dosing and throughout the study or are using an acceptable birth control
             method

          -  Females of non-childbearing potential must have undergone a sterilization procedure at
             least 6 months prior to dosing or are postmenopausal with amenorrhea for at least 1
             year prior to dosing and have follicle stimulating hormone (FSH) serum levels
             consistent with postmenopausal status

          -  Male subjects must agree not to donate sperm from dosing until 90 days after dosing

        Participants with Moderate or Severe Renal Insufficiency:

          -  Health of participant is stable based on medical history, laboratory tests and other
             assessments

          -  Clinical diagnosis of impaired stable renal function, and a creatinine clearance
             (CLcr) of <30 mL/min and not on hemodialysis for severe renal insufficiency
             participants, or 30 to <50 mL/min for moderate renal insufficiency participants

          -  No clinically significant change in renal status for at least 1 month prior to dosing,
             and is not currently or has not previously been on hemodialysis

        Healthy Control Participants:

          -  Participant is medically healthy based on laboratory tests and other assessments

          -  Age of the individual healthy participants in Part 1 of the study is aimed to be
             within the range of the mean age ± approximately 15 years of all participants with
             renal impairment in Part 1 of the study combined; this approach will also be applied
             with respect to age of participants in Part 2 of the study

          -  CLcr ≥80 mL/min

        Exclusion Criteria:

        All Participants:

          -  Mentally or legally incapacitated, significant emotional problems at screening or
             expected during the conduct of the study or history of a clinically significant
             psychiatric disorder over the last 5 years

          -  History or presence of significant cardiovascular, pulmonary, hepatic, renal,
             hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological
             disease whose current condition is considered unstable

          -  History or presence of alcoholism and drug abuse within the past 6 months

          -  History or presence of hypersensitivity or idiosyncratic reaction to the study
             medication or related compounds

          -  Female participants who are pregnant or lactating

          -  Positive results for the urine or saliva drug screen, or for the urine or breath
             alcohol screen

          -  Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus (HCV)

          -  Regular user of any medication (including over the counter) that would significantly
             alter renal function (e.g., cimetidine)

          -  Donation of blood or significant blood loss within 56 days prior to dosing, or
             donation of plasma within 7 days prior to dosing

          -  Participation in another clinical trial within 28 days prior to dosing

          -  No participant may be enrolled more than once within Part 1. Subjects who participate
             in Part 1 of study may be enrolled in Part 2, but participants within Part 2 are not
             to be enrolled more than once in Part 2

        Healthy Control Participants:

          -  Participant has had a renal transplant or has had nephrectomy