A Food-Effect Study for the Safety and Assessment of Pharmacokinetics of Navocaftor and Galicaftor.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Area under the plasma curve (AUC)
研究概览
简要总结
Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The objectives of this study are to assess the effect of food on the safety and pharmacokinetics of navocaftor and galicaftor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) is => 18.0 to <= 32.0 kg/ m2 after rounding to the tenth's decimal.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
排除标准
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- •Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
研究组 & 干预措施
Part 1: Navocaftor with food
Participants will receive navocaftor administered with food
干预措施: Navocaftor (Drug)
Part 1: Navocaftor without food
Participants will receive navocaftor administered without food
干预措施: Navocaftor (Drug)
Part 2: Galicaftor with food
Participants will receive galicaftor administered with food
干预措施: Galicaftor (Drug)
Part 2: Galicaftor without food
Participants will receive galicaftor administered without food
干预措施: Galicaftor (Drug)
结局指标
主要结局
Area under the plasma curve (AUC)
时间窗: Up to Day 4
AUC will be assessed.
Time to Cmax (peak time, Tmax)
时间窗: Up to Day 4
Tmax will be assessed.
Number of Participants with Adverse Events (AEs)
时间窗: Up to Day 38
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Terminal Elimination Half-life (t1/2)
时间窗: Up to Day 4
Terminal elimination half-life (t1/2) will be assessed.
Maximum Observed Plasma Concentration (Cmax)
时间窗: Up to Day 4
Cmax will be assessed.
次要结局
未报告次要终点