A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacodynamics And Pharmacokinetics of TRV734 in Healthy Adult Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Trevena Inc.
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.
详细描述
This will be conducted in two-parts enrolling a total of approximately 72 healthy volunteers.
- Part A will assess the safety, tolerability, PD and PK of a 125mg dose of TRV734 in an open-label, randomized, three-period crossover study in which subjects are fasted, fed a standard meal, or fed a high-fat meal.
- Part B of the trial will assess the safety, tolerability, PD and PK of multiple ascending doses of TRV734 in a double blind, double dummy, randomized, active- and placebo-controlled, adaptive study. Oxycodone immediate release (IR) 10 mg will be used as a benchmark.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by a responsible physician or trained qualified designee
- •Males (Part A) or males and females (Part B) between 18 & 64 years of age, inclusive. Females must be of non-childbearing
- •Capable of giving written informed consent
排除标准
- •Clinically significant conditions, or history of fainting or syncope
- •Medical or psychiatric illness
- •Major surgery within 4 weeks of screening
- •Known difficulty with obtaining intravenous access
- •Any ophthalmologic condition that could interfere with pupillometry
- •History of sensitivity to any of the investigational products, or known intolerance to opioids or a history of medication or other allergy
- •Use of prescription or non prescription medications
- •History of drug abuse within 6 months of screening
- •Use of any illegal drug within 30 days of screening and throughout participation in the study
- •History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
- •Donation of blood or plasma within 4 weeks prior to dosing
- •Participation in a clinical trial and has received a medication within 30 days
- •Weight <50 kg or BMI outside range of 18 - 32 kg/m2
- •Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
- •If male, unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of childbearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation
- •Part B Only:
- •Active dermatological condition or eczema on non-dominant hand.
- •Peripheral vascular disease
- •If female, of child bearing potential, pregnant or breastfeeding
研究组 & 干预措施
TRV734 125 mg
Part A, open-label will evaluate the the safety, PK and PD profile of a 125mg dose of TRV734 in which subjects are fasted, fed a standard meal, or fed a high-fat meal. Part A will also inform the dosing paradigm for Part B.
干预措施: Open-label TRV734 125 mg (Drug)
Multiple ascending dose study, active and placebo comparators
Part B will assess the safety, tolerability, PD and PK of TRV734. Subjects will be randomized in a ratio of 3:1:1 to receive either multiple doses of TRV734, oxycodone IR 10mg or placebo.
干预措施: TRV734 blinded (Drug)
Multiple ascending dose study, active and placebo comparators
Part B will assess the safety, tolerability, PD and PK of TRV734. Subjects will be randomized in a ratio of 3:1:1 to receive either multiple doses of TRV734, oxycodone IR 10mg or placebo.
干预措施: Oxycodone IR 10 mg (Drug)
Multiple ascending dose study, active and placebo comparators
Part B will assess the safety, tolerability, PD and PK of TRV734. Subjects will be randomized in a ratio of 3:1:1 to receive either multiple doses of TRV734, oxycodone IR 10mg or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety
时间窗: 7 days
Clinical safety data from adverse event reporting, clinical observations, 12-lead ECGs, cardiac telemetry monitoring, vital signs (blood pressure, heart rate, respiratory rate and oral temperature), oxygen saturation and safety laboratory tests.
次要结局
- Effect on pharmacodynamics of multiple ascending doses (Part B) of TRV734(4 days)
- Effect on pharmacodynamics of 125mg dose or TRV734 (Part A) following various administration paradigms(7 days)
- Effect on pharmacokinetics of multiple ascending (Part B) doses of TRV734(4 days)
- Effect on pharmacokinetics of 125mg dose of TRV734 (Part A) following various administration paradigms.(7 days)