NCT03880253已完成1 期
A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Healthy Volunteers
Concert Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年4月10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
- 30
- 试验地点
- 1
- 主要终点
- Measurement of CTP-692 exposure in plasma
研究概览
简要总结
This study will assess in healthy male and female subjects the safety and pharmacokinetic (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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 body mass index 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 Low Dose or Matching Placebo
Experimental
Once daily dosing
干预措施: CTP-692 (Drug)
CTP-692 Mid Dose or Matching Placebo
Experimental
Once daily dosing
干预措施: CTP-692 (Drug)
CTP-692 High Dose or Matching Placebo
Experimental
Once daily dosing
干预措施: CTP-692 (Drug)
结局指标
主要结局
Measurement of CTP-692 exposure in plasma
时间窗: Assessments done Day 1 - 9
Number of participants with adverse events as a measure of safety
时间窗: Assessments done Day 1 - 9
次要结局
未报告次要终点
研究者
研究点 (1)
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