ACTRN12620000522910已完成1 期
A Phase 1 Trial in Healthy Participants to Evaluate the Pharmacokinetics, Safety, Tolerability and Food Effects of Multiple Formulations of PRAX-114
Praxis Precision Medicines Australia, Pty Ltd0 个研究点目标入组 85 人开始时间: 2020年4月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Female or male and between the ages of 18 and 55 years, inclusive.
- •- Weight of at least 50 kg with body mass index (BMI) between 18 and 30 kg/m2 (inclusive).
排除标准
- •- Ongoing or history of any psychiatric, medical or surgical condition that might jeopardize the participant’s safety or interfere with the absorption, distribution, metabolism or excretion of the study drug.
- •- Any abnormal ECG findings, laboratory value or physical examination findings
- •- Positive breath test for ethanol, urine drug screen, urine cotinine test
- •- Use of systemic prescription medications or over-the-counter (OTC) medication, including multivitamins, and dietary and herbal supplement within 2 weeks
- •- Use of any experimental or investigational drug or device within 30 days
- •- Donation or loss of =400 mL blood within 8 weeks and/or donation of plasma within 7 days
研究者
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