Intervention: Sugammadex
Trial phase: Phase 1
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
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