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)

Conditions: Renal Impairment

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.

this is an open-label, 2-part single dose study: part 1 will include participants with mild, moderate, and severe renal impairment (as well as healthy control participants), and part 2 will include participants with end stage renal disease (esrd) undergoing hd. participants in part 1 will receive a single iv dose of mk-3866, and plasma and urine samples will be collected over pre-specified time intervals. participants in part 2 will receive a single iv dose of mk-3866 on two separate occasions: in period 1 immediately following their normally-scheduled hd, and in period 2 approximately 30 minutes prior to their normally-scheduled hd. plasma, urine, and dialysate samples will be collected over pre-specified time intervals for part 2.

Eligibility 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