pharmacokinetics of islatravir in participants with severe renal impairment (mk-8591-026)

Conditions: Human Immunodeficiency Virus (HIV) Infection

Summary: this study will evaluate the general tolerability and pharmacokinetics (pk) of a single 60 mg dose of mk-8591 (islatravir) in participants with severe renal insufficiency, compared to participants in good health.


Eligibility criteria:
inclusion criteria: healthy participants must have the following: * is in good health * has a body mass index (bmi) ≥18.5 and ≤40 kg/m2. * female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (wocbp); if a wocbp, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a wocbp must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention renally impaired participants must have the following: * with the exception of renal impairment, is in generally good health * has a bmi ≥ 18.5 and ≤ 40 kg/m2 * female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (wocbp); if a wocbp, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a wocbp must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention exclusion criteria: healthy participants must have the following: * has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. * is mentally or legally incapacitated, has significant emotional problems * has known hypersensitivity to the active substance or any of the excipients of the study drug * has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food. * is positive for hepatitis b surface antigen, hepatitis c antibodies or hiv. * had major surgery, donated or lost 1 unit of blood (approximately 500 ml) within prior 4 weeks * is taking medications to treat chronic medical conditions and/or conditions associated with renal disease * has participated in another investigational study within prior 4 weeks other exclusions for healthy participants: * does not agree to follow the smoking restrictions * consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day * consumes excessive amounts,of caffeinated beverages per day. * is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately prior 3 months. renally impaired participants must have the following: * has a history or presence of renal artery stenosis. * has had a renal transplant or nephrectomy. * has rapidly fluctuating renal function as determined by historical measurements. * has known hypersensitivity to the active substance or any of the excipients of the study drug. * has a history of cancer (malignancy). * has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food. * is positive for hepatitis b surface antigen, hepatitis c antibodies or human immunodeficiency virus (hiv). * had major surgery, donated or lost 1 unit of blood (approximately 500 ml) within 4 weeks prior to the prestudy (screening) visit. * is taking medications to treat chronic medical conditions and/or conditions associated with renal disease and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 8 hours after administration of the study drug. * has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit. other exclusions for renally impaired participants * does not agree to follow the smoking restrictions. * consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day. * consumes excessive amounts of caffeinated beverages per day. * is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months.