NCT03880136已完成1 期
A Phase 1 Single Center, Open-Label, Randomized Two-Period, Two-Arm Crossover Study of the Relative Bioavailability of a Single Dose of CTP-543 in Fasted and Fed Conditions in Healthy Volunteers
Concert Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年3月25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
- 14
- 试验地点
- 1
- 主要终点
- Measurement of CTP-543 in plasma under fed and fasted conditions
研究概览
简要总结
Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.
详细描述
This open-label, single-dose study will assess in healthy subjects a solid oral dose formulation of CTP-543 under fasted and fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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 adults between 18 and 55 years of age, inclusive
- •Body weight not less than 100 lbs and body mass index within the range of 18 to 32 kg/m2, inclusive, at screening
排除标准
- •History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions
- •PR interval > 220 msec or QRS duration > 120 msec or QTcF interval > 450 msec obtained at screening visit 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 at screening
- •Urinalysis positive for greater than trace blood, protein or glucose
- •History of drug or alcohol abuse within 6 months of screening
- •History of tobacco product use within 3 months prior to the study
- •Inability to comply with dietary restrictions during study participation
- •Blood donation or collection within 8 week prior to dosing
- •Positive pregnancy test
研究组 & 干预措施
Sequence 1
Experimental
Period 1: CTP-543 with meal Period 2: CTP-543 without meal
干预措施: CTP-543 (Drug)
Sequence 2
Experimental
Period 1: CTP-543 without meal Period 2: CTP-543 with meal
干预措施: CTP-543 (Drug)
结局指标
主要结局
Measurement of CTP-543 in plasma under fed and fasted 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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