ACTRN12622001021763已完成1 期
A Randomized, Positive- and Placebo-Controlled Study to Evaluate the Effects of ONC201 on Cardiac Repolarization in Healthy Participants - Part 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
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
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Male or female between 18 to 45 years of age
- •Female must be of non-childbearing potential
- •Body weight greater than 50 kg, body mass index between 18–30 kg/m2
- •Healthy Volunteers who are overtly healthy as determined by medical evaluation and judgment of the investigator including medical history, PE, laboratory tests, vital signs, and cardiac monitoring.
排除标准
- •Have a positive serological test result at the screening evaluation consistent with possible infection with HBV, HCV, or HIV.
- •Have a positive pregnancy test at screening or Period 1 Day -1
- •Current history of moderate to heavy tobacco/nicotine use
- •Abnormal 12-lead ECG at Screening or Period 1 Day -1,
- •Resting supine heart rate less than 45 beats per minute or greater than 100 beats per minute
- •Any clinically significant abnormal findings during physical examination or medical history
研究者
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