NCT05877222已完成1 期
A Single-center, Open-label, Randomized, Crossover Phase 1 Trial to Investigate Bioequivalence Between 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
A Phase 1 trial to investigate bioequivalence between 5 × 10 mg tablets and 2 × 25 mg tablets of daridorexant in healthy male and female Japanese participants
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent in a language understandable to the participant prior to any trial-mandated procedure.
- •Healthy male and female participants aged between 18 and 65 years (inclusive) at Screening.
- •Body mass index of 18.5 to 29.9 kg/m2 (inclusive) at Screening.
- •Participant must be of native Japanese descent (all parents/grandparents of Japanese descent).
- •Participant must not have been away from Japan for more than 10 years (at Screening visit).
- •Participant's lifestyle should not have changed significantly since relocation from Japan.
排除标准
- •Known hypersensitivity to daridorexant, or any of its excipients.
- •History of narcolepsy or cataplexy.
- •Clinically relevant findings on the physical examination at Screening.
- •Clinically relevant findings on 12-lead ECG, recorded after 5 min in a supine position at Screening.
- •Clinically relevant findings in clinical laboratory tests (hematology and clinical chemistry) at Screening.
- •Clinically relevant findings in systolic blood pressure, diastolic blood pressure, and pulse rate, measured on either arm, after 5 min in the supine position at Screening.
- •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 (appendectomy and herniotomy allowed if performed > 12 weeks prior to administration of first study treatment, 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.
研究组 & 干预措施
Treatment B (5 × 25 mg daridorexant)
Experimental
Participants will receive a single oral dose of 2 × 25 mg daridorexant.
干预措施: Daridorexant 25 mg (Drug)
Treatment A (5 × 10 mg daridorexant)
Experimental
Participants will receive a single oral dose of 5 × 10 mg daridorexant.
干预措施: Daridorexant 10 mg (Drug)
结局指标
主要结局
Cmax
时间窗: Blood samples for PK analysis will be taken at several timepoints from treatment administration on Day 1 to Day 3 of Study periods 1 and 2 (Total duration: up to 4 days)
AUC0-t
时间窗: Blood samples for PK analysis will be taken at several timepoints from treatment administration on Day 1 to Day 3 of Study periods 1 and 2 (Total duration: up to 4 days)
次要结局
未报告次要终点
研究者
研究点 (1)
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