NCT05487404已完成1 期
A Double-Blind Clinical Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Subjects With Serious Adverse Events
研究概览
简要总结
A Double-Blind Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects between the ages of 21 and 65 years, inclusive, at Screening;
- •Subjects with the ability to obtain transportation to and from the study site;
- •Subjects who agree to abstain from consumption of non-study alcohol during the study.
排除标准
- •Subjects with abnormal laboratory values of clinical significance, at the discretion of the Investigator, at Screening;
- •Subjects with nicotine product use within 14 days prior to Screening until the end of the study;
- •Subjects with any history of or current alcohol or other substance use disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition;
- •Subjects with a positive urine drug screen or breath alcohol test at Screening or Check-In (both treatment periods).
研究组 & 干预措施
ADX-629 Oral Tablets
Experimental
干预措施: ADX-629 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Serious Adverse Events
时间窗: The safety assessment period was approximately two days for each treatment period.
Safety was assessed through serious adverse event collection.
次要结局
- Change From Baseline of Dermal Flushing(The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.)
- Change From Baseline for Romberg Test(The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.)
研究者
研究点 (1)
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