NCT02344303已完成1 期
A Single-dose, Open-label, Fixed Sequence, Two Period Cross Over Study to Assess the Tolerability of a Supra Therapeutic Dose of TRV130 Followed by A Single Dose, Randomized, Double Blind, Comparative, Positive and Placebo Controlled, Four Period Cross-over Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on the QTc Intervals in Healthy Subjects
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
- 63
- 主要终点
- Part B - Change from baseline in QTc
研究概览
简要总结
Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and supratherapeutic doses.
详细描述
- Part A of the study will assess clinical safety data of TRV130
- Part B of the study will assess the effect of single dose TRV130 on QTc
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects between the ages of 18 and 45 inclusive.
- •Women must be either a) post-menopausal; b) surgically sterile; c) of child-bearing potential and practicing contraception or remaining sexually inactive.
- •Men must be willing to abstain from sperm donation from the time of Screening through the Follow-up Visit and, if sexually active with a woman of child-bearing potential, must be protected by acceptable forms of effective contraception through the Follow-up Visit.
排除标准
- •Past or present diseases including, but not limited to, significant medical abnormalities including: psychiatric, neurologic, pulmonary, cardiac, gastrointestinal, genitourinary, renal, metabolic, endocrinologic or autoimmune disorders.
- •Has previously participated in another TRV130 clinical study.
研究组 & 干预措施
Part A
Experimental
Fixed sequence, open label
干预措施: TRV130 (Drug)
Part B
Experimental
4 way cross over, double blind
干预措施: TRV130 (Drug)
Part B
Experimental
4 way cross over, double blind
干预措施: Moxifloxacin (Drug)
Part B
Experimental
4 way cross over, double blind
干预措施: Placebo (Drug)
结局指标
主要结局
Part B - Change from baseline in QTc
时间窗: Prior to dose through 24 hours
Part A - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: Prior to dose through 4 hours
次要结局
- Part B - Pharmacodynamics - QTc(Prior to dose through 24 hours)
- Part B - Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Prior to dose through Follow-Up Visit)
- Part A & B - Pharmacokinetics - Cmax, tmax, AUC(Prior to dose through 24 hours)
研究者
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