An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-1439 (Doravirine) in Subjects With Severe Renal Impairment

Merck Sharp & Dohme LLC0 个研究点目标入组 16 人开始时间: 2016年1月26日最近更新: 2019年2月8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: 16
主要终点: Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine

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记录与标识符相似试验

研究概览

简要总结

This study will evaluate the effect of severe renal impairment on the pharmacokinetics of doravirine.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
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

•is a non-smoker or moderate smoker
•has a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m^2
•other than renal impairment, participant is judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests
•female informed of the risks of pregnancy, agree not to become pregnant while participating in this study. Female of childbearing potential must either be sexually inactive for 14 days prior to dosing and throughout the study, or uses one acceptable birth control method
•female of non-childbearing potential must have undergone sterilization procedures at least 6 months prior to dosing.
•Participants with severe renal impairment only: has baseline estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2

排除标准

•is mentally or legally incapacitated or has significant emotional problems
•has a history or presence of clinically significant medical or psychiatric condition or disease
•has history or presence of alcoholism or drug abuse within the past 2 years
•has history or presence of hypersensitivity or idiosyncratic reaction to the study drug, any inactive ingredients, or related compounds
•has history or presence of renal artery stenosis
•has had a renal transplant or nephrectomy
•has rapidly fluctuating renal function as determined by historical measurements
•female is pregnant or lactating
•has positive results for the urine or saliva drug and urine or breath alcohol screen at screening or check-in
•has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
•is unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Certain medications including those to treat kidney disease will be permitted. Other medications may be permitted following consultation with the Sponsor Clinical Monitor.
•is unable to refrain from or anticipates the use of inducers of cytochrome P450 3A (CYP3A) or permeability glycoprotein (P-gp) transporters for at least 28 days prior to dosing and throughout the study.
•has been on a diet incompatible with the on-study diet, within 28 days prior to dosing, and throughout the study
•has donated blood or had significant blood loss within 56 days prior to dosing
•has donated plasma within 7 days prior to dosing
•has participated in another clinical trial within 28 days prior to dosing

研究组 & 干预措施

Healthy Matched Control

Experimental

Healthy participants matched for age and weight receive a single oral dose of 100 mg doravirine

干预措施: Doravirine (Drug)

Severe Renal Impairment

Experimental

Participants with severe renal impairment receive a single oral dose of 100 mg doravirine

干预措施: Doravirine (Drug)

结局指标

主要结局

Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine

时间窗: Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment