NCT04250506已完成1 期
A Single-center, Randomized, Double-blind, Placebo- and Moxifloxacin-controlled, Phase 1 Study to Assess the Effect of Single Therapeutic and Supratherapeutic Doses of Daridorexant on the QT Interval Duration in Healthy Subjects
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
- 36
- 试验地点
- 1
- 主要终点
- Placebo-corrected change from baseline in the HR-corrected QTcF (ΔΔQTcF)
研究概览
简要总结
A study to assess the effect of single doses of daridorexant on electrocardiogram parameters in healthy subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed informed consent in the local language prior to any study-mandated procedure.
- •Czech citizen with the ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the requirements of the study.
- •Healthy male and female subjects aged 18 to 55 years (inclusive) at Screening.
- •12-lead safety ECG: QTcF < 450 ms for male subjects and < 470 ms for female subjects, QRS < 110 ms, and PR < 220 ms, and resting HR > 50 bpm and < 90 bpm with no clinically relevant abnormalities on 12-lead ECG after 5 min in the supine position at Screening and on Day 1 pre-dose of Period
- •Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
- •Women of childbearing potential are eligible only if the following applies:
- •Negative serum pregnancy test at Screening.
- •Negative serum pregnancy test on Day 1 of the first period.
- •Agreement to consistently and correctly use a highly effective method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner from Screening up to at least 30 days after last study treatment administration in the last period with wash-out periods included. If a hormonal contraceptive is used, it must be initiated at least 1 month before first treatment administration.
- •Women of non-childbearing potential must meet at least one of the following criteria:
- •Previous bilateral salpingectomy, salpingo-oophorectomy, or hysterectomy.
- •Premature ovarian failure confirmed by a specialist gynecologist.
- •Post-menopausal, defined as 12 consecutive months with amenorrhea prior to Screening without alternative medical cause and confirmed with follicle-stimulating hormone (FSH) test.
- •XY genotype.
- •Turner syndrome.
- •Uterine agenesis.
排除标准
- •Pregnant or lactating women.
- •Previous exposure to daridorexant.
- •Known hypersensitivity to moxifloxacin or any of the drug product excipients or to other fluoroquinolone antibiotics.
- •Any contraindication to moxifloxacin treatment.
- •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 treatments (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.
- •History or presence of rhythm disorders (e.g., sinoatrial heart block, sick-sinus syndrome, second- or third-degree atrioventricular block, long QT syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation) or electrolyte disturbances, particularly hypokalemia.
- •Any sleep-disorder including self-reported insomnia disorder, breathing-related sleep disorders, restless legs syndrome, nightmare disorder, non-rapid eye movement sleep arousal disorders (sleep terror disorder or sleepwalking disorder), rapid eye movement sleep behavior disorder, circadian rhythm sleep-wake disorders.
研究组 & 干预措施
Treatment A: Daridorexant 50 mg
Experimental
Daridorexant (ACT-541468) administered as film-coated tablets for oral use.
干预措施: Daridorexant (Drug)
Treatment B: Daridorexant 200 mg
Experimental
Daridorexant (ACT-541468) administered as film-coated tablets (4 x 50 mg) for oral use.
干预措施: Daridorexant (Drug)
Treatment C: Placebo
Placebo Comparator
Placebo administered as tablets (4 x 50 mg) for oral use.
干预措施: Placebo (Drug)
Treatment D: Moxifloxacin 400 mg
Active Comparator
Moxifloxacin administered as film-coated tablets for oral use.
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Placebo-corrected change from baseline in the HR-corrected QTcF (ΔΔQTcF)
时间窗: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks.
次要结局
- Plasma PK parameters of daridorexant: - AUC from 0 to 24 hours (AUC0-24)(Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks.)
- Plasma PK parameters of daridorexant: - T½(Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks.)
- Plasma PK parameters of daridorexant: - Maximum plasma concentration (Cmax)(Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks.)
- Plasma PK parameters of daridorexant: - Time to reach Cmax (tmax)(Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of Daridorexant in Chinese Patients With Insomnia DisorderInsomnia DisorderNCT06010693Jiangsu Simcere Pharmaceutical Co., Ltd.206
已完成
1 期
Electrocardiographic (ECG) Safety Study of Droxidopa at Clinical and Supratherapeutic DoseQTc IntervalNCT01327066Chelsea Therapeutics52
已完成
1 期
A Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat Under Fed and Fasted ConditionsHealthy ParticipantsNCT01619527Janssen R&D Ireland133
已完成
3 期
A Trial With Dronedarone to Prevent Hospitalization or Death in Patients With Atrial FibrillationAtrial FibrillationAtrial FlutterNCT00174785Sanofi4,628
已完成
1 期
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy ParticipantsHealthyNCT03320707Janssen Research & Development, LLC66