Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)

• Status: Completed
• Trial end date: 2018-02-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3866 is removed from the plasma by hemodialysis (HD), and evaluate the safety and tolerability of MK-3866 in participants with impaired renal function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Females of non-childbearing potential. Male participants with female partner(s) of child-bearing potential agree to use a medically acceptable method of contraception during the study and for 90 days after dosing. If partner is pregnant, males agree to use a condom; if partner is of child-bearing potential, partner must use additional birth control

• Male participants agree not to donate sperm from the first dose until 90 days after dosing

• Adequate venous access

Renal Impaired Participants

• Liver function tests (serum alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) and serum bilirubin (total and direct) within upper limit of normal

• Panels A, B, and C: no clinically significant change in renal status at least 1 month prior to dosing and not currently or previously been on hemodialysis

• Panel E only: ESRD maintained on stable regimen of at least 3 times per week HD for at least 3 months prior to first dosing

Healthy Participants

• Age within ± 15 years of the mean age of participants with impaired renal function to which the healthy participant is matched

• Medically healthy as per medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory safety tests

• Blood urea nitrogen, liver function tests (ALT, AST, alkaline phosphatase [ALP]), and serum bilirubin (total and direct) within upper limit of normal.

Exclusion Criteria:

• Mentally/legally incapacitated, or significant emotional problems or significant psychiatric disorder

• History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, respiratory, genitourinary or major neurological abnormalities or diseases

• History of any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study

• Clinically significant history of cancer

• Smoker and/or has used nicotine or nicotine-containing products within 3 months prior to screening

• Female participants of childbearing potential, pregnant, or lactating

• Positive results for urine or saliva drug screen and/or urine or breath alcohol screen at screening or check-in

• Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

• Consumes more than 3 glasses of alcoholic beverages within 6 months of screening

• Consumes excessive amounts of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day

• Major surgery, donated or lost 1 unit of blood within 4 weeks prior to screening, or donated plasma within 7 days prior to dosing in Part 1 or first dose in Part 2

Renal Impaired Participants

• Panels A, B, and C: Failed renal transplant or has had nephrectomy

• Panels A, B, and C: Rapidly fluctuating renal function, as determined by historical measurements; or demonstrated/suspected renal artery stenosis

• Panel E only: Has required frequent emergent HD (≥3) within a year prior to first dosing

Healthy Participants

• Renal transplant or nephrectomy