NCT03284164已完成1 期
An Open-Label Study to Investigate the Effect of Renal Impairment on the Pharmacokinectics of Tenofovir Exalidex
ContraVir Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年9月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
研究概览
简要总结
This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex
详细描述
This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and severe) on the pharmacokinetics of Tenofovir Exalidex
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years of age and over
- •Capable of giving written informed consent
- •Capable of completing study requirements
排除标准
- •Positive result for HIV, HBV, or HCV
- •History or medical condition which could impact patient safety
- •Current or past abuse of alcohol or drugs
- •Participation in another clinical trial within the past 30 days
研究组 & 干预措施
Healthy Subjects
Experimental
Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)
干预措施: Tenofovir Exalidex (TXL) (Drug)
Severe RI
Experimental
Severe Renal Impairment subjects Tenofovir Exalidex (TXL)
干预措施: Tenofovir Exalidex (TXL) (Drug)
结局指标
主要结局
Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
时间窗: up to six days post dose
Measuring Cmax : the peak plasma concentration
次要结局
- Evaluation of the adverse events for TXL in RI subjects(up to six days post dose)
- Evaluation of safety labs for TXL in RI subjects(up to six days post dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of the Effect of Renal Impairment on the Activity of GK Activator (2) in Patients With Type 2 Diabetes.Diabetes Mellitus Type 2NCT00368368Hoffmann-La Roche5
已完成
1 期
A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal FunctionRenal ImpairmentNCT05940402AbbVie58
已完成
1 期
Study to Evaluate GLPG0634 in Subjects With Renal Impairment Compared to Healthy SubjectsRenal ImpairmentNCT02084199Galapagos NV24
已完成
1 期
Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)Renal ImpairmentType 2 Diabetes MellitusNCT01948986Merck Sharp & Dohme LLC36
已完成
1 期
A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)Overactive BladderNCT01628042Merck Sharp & Dohme LLC32