A Phase 1 Single Center, Open-Label, Randomized, Three-Way Crossover Study of the Relative Bioavailability of a Single Dose of CTP-656 in a Fasted, Fed Low-Fat and Fed Moderate-Fat Condition in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Measurement of CTP-656 in plasma under fed and fasted conditions
研究概览
简要总结
Three way crossover study to assess the bioavailability of 656 under fed and fasted conditions.
详细描述
This study will assess in healthy male subjects a solid oral dose formulation of CTP-656 under fasted and fed conditions.
Primary:
• To characterize the relative bioavailability and pharmacokinetic profile of a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.
Secondary:
- To characterize the pharmacokinetic profile of metabolites of CTP-656 following a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.
- To assess the safety and tolerability following a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between 18 and 50 years of age, inclusive
- •Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening
排除标准
- •History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) 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
- •Liver function tests greater than the upper limit of normal.
- •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
- •A positive screen for alcohol, drugs of abuse, or tobacco use.
- •Inability to comply with dietary restrictions during study participation.
- •Donation or blood collection or acute loss of blood prior to screening.
研究组 & 干预措施
CTP-656 Fed, low fat
Single dose of CTP-656 150 mg administered after a low-fat breakfast
干预措施: CTP-656 (Drug)
CTP-656 Fasted
Single dose of CTP-656 150 mg administered fasted
干预措施: CTP-656 (Drug)
CTP-656 Fed, high fat
Single dose of CTP-656 150 mg administered after a moderate-fat breakfast
干预措施: CTP-656 (Drug)
结局指标
主要结局
Measurement of CTP-656 in plasma under fed and fasted conditions
时间窗: 96 hours
Geometric mean ratio of moderate-fat versus low-fat or fasted
次要结局
未报告次要终点