Single-center, Randomized, Open-label Study to Investigate the Effect of Single-dose Famotidine and Multiple-dose Efavirenz on the Pharmacokinetics of Daridorexant in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- PK parameter of daridorexant: Terminal elimination half-life (t½)
研究概览
简要总结
A study in healthy male subjects to investigate the effect of famotidine and efavirenz on the way the body takes up, distributes, and gets rid of daridorexant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- •Healthy male subjects aged between 18 and 45 years (inclusive) at Screening.
排除标准
- •Clinically relevant findings on the physical examination at Screening.
- •Clinically relevant abnormalities on 12-lead ECG, measured after at least 5 min in a supine position at Screening.
- •Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry) at Screening and on Day -
- •History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- •Moderate or severe renal insufficiency (creatinine clearance < 60 mL/min calculated with the Cockcroft Gault formula) at Screening.
- •Total bilirubin > 1.5 x Upper Limit of Normal at Screening.
研究组 & 干预措施
Treatment A: Daridorexant
Single dose of 50 mg daridorexant
干预措施: Daridorexant (Drug)
Treatment B: Famotidine & daridorexant
Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant
干预措施: Daridorexant (Drug)
Treatment B: Famotidine & daridorexant
Single dose of 40 mg famotidine followed 3 h later by a single dose of 50 mg daridorexant
干预措施: Famotidine (Drug)
Treatment C: Efavirenz
600 mg efavirenz once daily in the evening from Day 5 to Day 14
干预措施: Efavirenz (Drug)
Treatment D: Daridorexant & efavirenz
Single dose of 50 mg daridorexant in the morning of Day 15 followed by a single dose of 600 mg efavirenz in the evening of Days 15 and 16
干预措施: Daridorexant (Drug)
Treatment D: Daridorexant & efavirenz
Single dose of 50 mg daridorexant in the morning of Day 15 followed by a single dose of 600 mg efavirenz in the evening of Days 15 and 16
干预措施: Efavirenz (Drug)
结局指标
主要结局
PK parameter of daridorexant: Terminal elimination half-life (t½)
时间窗: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: AUC from zero to infinity (AUC0-inf)
时间窗: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: Time to reach Cmax (tmax)
时间窗: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: AUC from zero to 48 hours (AUC0-48)
时间窗: Various time points during Treatment A through D (Total duration: up to 3 weeks).
PK parameter of daridorexant: Maximum plasma concentration (Cmax)
时间窗: Various time points during Treatment A through D (Total duration: up to 3 weeks).
次要结局
- Treatment-emergent (S)AEs(Up to EOP for each of the Periods 1 to 3 and up to EOS for Period 4 (Total duration: up to 3 months))