NCT01514578已完成1 期
A Multi-Part, Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TRV130A in Healthy Adult Males
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
- Trevena Inc.
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male 19 - 50 years of age
- •Body weight >/= 50 kg
- •Capable of giving written informed consent
排除标准
- •Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study
- •Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; elevations of aspartate aminotransferase or alanine aminotransferase; positive drug or alcohol test; positive urine test for cotinine
- •Major surgery within 4 weeks of screening
研究组 & 干预措施
TRV130A
Experimental
干预措施: TRV130A (Drug)
Dextrose in Water
Placebo Comparator
干预措施: Dextrose in Water (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: Baseline to 8 days after dose administration
Area under the plasma concentration versus time curve of TRV130A
时间窗: Baseline to 24 hours after dose administration
次要结局
- Effect of TRV130A on pain perception using cold pain test(Baseline to 3 hours after dose administration)
- Effect of TRV130A on pupil diameter(Baseline to 3 hours after dose administration)
- Effect of TRV130A on eye movements(Baseline to 3 hours after dose administration)
- Effect of TRV130A on sedation(Baseline to 3 hours after dose administration)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of TRV130 for the Treatment of Pain After BunionectomyAcute PainNCT02100748Trevena Inc.333
已完成
2 期
A Study of TRV130 for the Treatment of Pain After AbdominoplastyPainNCT02335294Trevena Inc.200
已完成
1 期
Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy SubjectsPain, AcuteNCT02083315Trevena Inc.30
终止
2 期
A Pilot Study of TRV130 for the Treatment of Fracture PainPainNCT02520297Trevena Inc.1
终止
2 期
Study Evaluating the Efficacy of DVS-233 in FibromyalgiaFibromyalgiaNCT00301431Wyeth is now a wholly owned subsidiary of Pfizer1,050