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

NCT ID: NCT02011490

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-11
• Study Completion Date: 2014-06-06

Brief 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.

Detailed Description

In each study period (i.e., Part 1 and Part 2), day of drug administration was defined to be Day 1.

Conditions

Renal Insufficiency; Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Severe Renal Insufficiency Participants: Part 1

Participants with severe renal insufficiency will receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. Dose will be administered by direct injection into a peripheral vein.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

sugammadex 4 mg/kg IV bolus

Moderate Renal Insufficiency Participants: Part 1

Participants with moderate renal insufficiency will receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. Dose will be administered by direct injection into a peripheral vein.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

sugammadex 4 mg/kg IV bolus

Healthy Control Participants: Part 1

Healthy control participants will receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. Dose will be administered by direct injection into a peripheral vein.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

sugammadex 4 mg/kg IV bolus

Severe Renal Insufficiency Participants: Part 2

Participants with severe renal insufficiency will receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. Dose will be 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 will be confirmed immediately prior to dose administration, and dose will be followed by saline flush.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

sugammadex 4 mg/kg IV bolus

Moderate Renal Insufficiency Participants: Part 2

Participants with moderate renal insufficiency will receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. Dose will be 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 will be confirmed immediately prior to dose administration, and dose will be followed by saline flush.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

sugammadex 4 mg/kg IV bolus

Healthy Control Participants: Part 2

Healthy control participants will receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. Dose will be 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 will be confirmed immediately prior to dose administration, and dose will be followed by saline flush.

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

sugammadex 4 mg/kg IV bolus

Interventions

sugammadex

sugammadex 4 mg/kg IV bolus

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Investigational Site 001

Hialeah, Florida, United States

Countries

United States

References

Min KC, Lasseter KC, Marbury TC, Wrishko RE, Hanley WD, Wolford DG, Udo de Haes J, Reitmann C, Gutstein DE. Pharmacokinetics of sugammadex in subjects with moderate and severe renal impairment . Int J Clin Pharmacol Ther. 2017 Sep;55(9):746-752. doi: 10.5414/CP203025.

Reference Type: RESULT

PMID: 28679468 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

8616-105

Identifier Type: -

Identifier Source: org_study_id