An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Islatravir (MK-8591) in Subjects With Severe Renal Impairment

Merck Sharp & Dohme LLC2 个研究点分布在 2 个国家目标入组 12 人开始时间: 2020年6月18日最近更新: 2021年10月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 12
试验地点: 2
主要终点: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Plasma Islatravir (ISL)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy participants must have the following:
•Is in good health
•Has a body mass index (BMI) ≥18.5 and ≤40 kg/m
•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

排除标准

•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.

研究组 & 干预措施

Severe Renal Impairment

Experimental

Participants with severe renal impairment received a single oral dose of 60 mg MK-8591 (Islatravir) administered in capsule form.

干预措施: Islatravir (Drug)

Healthy

Experimental

Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form.

干预措施: Islatravir (Drug)