A Randomized, Single-Blind, Placebo-Controlled, Adaptive, Ascending Dose Study to Evaluate the Effects of TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Mild to Moderate Renal Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Trevena Inc.
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Change from Baseline Glomerular Filtration Rate
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent
- •Heart Failure
- •Mild to moderate renal dysfunction
- •Age 18- <75
- •Males and females (non-childbearing potential)
排除标准
- •Any significant disease or condition that would interfere with the interpretation of safety or efficacy or efficacy data as determined by the Investigator based on medical history, physical examination or laboratory tests
- •Any other serious life threatening disease that may impair the interpretation of safety or efficacy data from the study as determined by the Investigator
- •Allergy or clinically-significant intolerance to ARBs or ACE inhibitors
- •Clinical signs or symptoms of acute decompensated heart failure
- •Pregnant or lactating
研究组 & 干预措施
TRV120027
TRV120027 administered as an IV infusion
干预措施: TRV120027 (Drug)
Normal Saline
Normal Saline administered as an IV infusion
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change from Baseline Glomerular Filtration Rate
时间窗: Every hour during final 6 hours of study drug infusion
Assessments of glomerular filtration rate are made hourly during the 6-hour study drug infusion on study Day 1 and study Day 3. GFR in hours 4-6 are compared to GFR in hours 1-3, and comparisons made between Placebo and TRV120027.
Change from Baseline in Vital Signs (Blood pressure, heart rate)
时间窗: Baseline, during infusion, and following infusion, on Study Day 1 and Study Day 3
Vital signs measurements made during and following drug infusion will be evaluated as a change from baseline, and comparing placebo to TRV120027. Assessments are made on study Day 1 and study Day 3.
次要结局
未报告次要终点