NCT03830463已完成1 期
A Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Fed and Fasted Conditions in Healthy Volunteers
Concert Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年1月24日最近更新:
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
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety
研究概览
简要总结
This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and females between 18 and 55 years of age, inclusive
- •Body weight ≥ 55 kg and BMI within the range of 18 to 32 kg/m2, inclusive
排除标准
- •Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug
- •Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody
- •History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
- •Positive drug or alcohol test at screening or prior to the first dose of study drug
研究组 & 干预措施
CTP-692
Experimental
干预措施: CTP-692 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety
时间窗: 48 hours
Measurement of CTP-692 exposure in plasma under fasted conditions
时间窗: 48 hours
Measurement of CTP-692 exposure in plasma under fed conditions
时间窗: 48 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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