A Two-Part Open-Label, Randomized, Sequential, Crossover, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of C-10355 and C-10358 in Healthy Volunteers, With a PK Comparison to Kalydeco®
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
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This two-part study will assess, in healthy volunteers, under both fasted and fed conditions, and in a sequential manner, the safety, tolerability and pharmacokinetics (PK) profile of single doses of C-10355 and C-10358 and single ascending doses of the selected compound compared to a single dose of Kalydeco®.
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
- All
- 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 food and beverage restrictions during study participation.
- •Donation or blood collection or acute loss of blood prior to screening.
研究组 & 干预措施
C-10358, 25 mg
single oral dose.
干预措施: C-10358 (Drug)
C-10355, 25 mg
single oral dose.
干预措施: C-10355 (Drug)
C-10355 or C-10358, 75 mg
single oral dose.
干预措施: C-10355 (Drug)
C-10355 or C-10358, 75 mg
single oral dose.
干预措施: C-10358 (Drug)
C-10355 or C-10358, 150 mg
single oral dose.
干预措施: C-10355 (Drug)
C-10355 or C-10358, 150 mg
single oral dose.
干预措施: C-10358 (Drug)
Kalydeco, 150 mg
single oral dose.
干预措施: Kalydeco (Drug)
C-10355 or C-10358, 300 mg
single oral dose.
干预措施: C-10355 (Drug)
C-10355 or C-10358, 300 mg
single oral dose.
干预措施: C-10358 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 24 hours
adverse events categorized by body system and MedDRA term
Pharmacokinetic Profile
时间窗: 96 hours
Measure exposure of test articles using area under the concentration time curve (AUC), maximum concentration (Cmax), half life (T 1/2)
次要结局
未报告次要终点