Pharmacokinetics of Sugammadex (MK-8616) in Participants With Moderate and Severe Renal Insufficiency (MK-8616-105)

This is an interventional treatment trial for Renal Insufficiency Read More

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