A Phase 1 Open-label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Icalcaprant in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Icalcaprant
研究概览
简要总结
This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
排除标准
- •History of any clinically significant sensitivity or allergy to any medication or food.
- •Exposure to icalcaprant within the past 90 days.
- •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.].
研究组 & 干预措施
Icalcaprant with Itraconazole
Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days.
干预措施: Icalcaprant (Drug)
Icalcaprant with Itraconazole
Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days.
干预措施: Itraconazole (ITZ) (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Icalcaprant
时间窗: Up to approximately 14 days
Cmax of Icalcaprant
Time to Cmax (Tmax) of Icalcaprant
时间窗: Up to approximately 14 days
Tmax of Icalcaprant
Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant
时间窗: Up to approximately 14 days
Beta of Icalcaprant
Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant
时间窗: Up to approximately 14 days
T1/2 of Icalcaprant
Area under the plasma concentration-time curve (AUC) of Icalcaprant
时间窗: Up to approximately 14 days
AUC of Icalcaprant
Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant
时间窗: Up to approximately 14 days
AUCt of Icalcaprant
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant
时间窗: Up to approximately 14 days
AUCinf of Icalcaprant
Number of Participants with Adverse Events (AEs)
时间窗: Up to approximately 47 days
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. The investigator assesses the relationship of each event to the use of study
次要结局
未报告次要终点