NL-OMON45918已完成不适用
A double-blind, randomized, placebo-controlled, double-dummy, four-way crossover study to investigate the drug-drug interactions between ACT-541468 and ethanol in healthy subjects - Interaction study with ACT-541468 and ethanol in healthy subjects.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- •2. Healthy male and female subjects aged between 18 and 45 years (inclusive) at screening.
- •3. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use (from screening, during the entire study, and for at least 90 days after last study treatment intake) a reliable method of contraception with a failure rate of <1% per year, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated at least 1 month before first treatment administration.
- •4. Women of non-childbearing potential (i.e., postmenopausal [defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicle-stimulating hormone test], with previous bilateral salpingectomy, bilateral salpingo-oophorectomy or hysterectomy, or with premature ovarian failure [confirmed by a specialist], XY genotype, Turner syndrome, uterine agenesis).
- •5. Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening.
- •6. No clinically relevant findings on the physical examination at screening.
- •7. Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on either arm, after 5 min in the supine position at screening.
- •8. 12-lead ECG without clinically relevant abnormalities, measured after 5 min in the supine position at screening.
- •9. No clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) at screening.
- •10. Negative results from urine drug screen and breath alcohol test at screening and on Day 1 pre-dose.
- •11. 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.
- •12. Previous experience with alcohol consumption and, therefore, familiar with the effects of alcohol.
排除标准
- •1. Pregnant or lactating women.
- •2. Known hypersensitivity to ACT-541468 or treatments of the same class, or any of its excipients.
- •3. 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).
- •4. Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study.
- •5. Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- •6. Veins unsuitable for intravenous (i.v.) puncture on either arm (e.g., veins that are difficult to locate, access, or puncture, veins with a tendency to rupture during or after puncture).
- •7. Participation in a clinical study involving study treatment administration within 3 months prior to screening or in more than 4 clinical studies within 1 year prior to screening.
- •8. Excessive caffeine consumption, defined as 800 mg per day at screening
- •9. Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) within 3 months prior to screening and inability to refrain from nicotine intake from screening until End-of-Study (EOS).
- •10. Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John*s Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first study treatment administration.
- •11. Loss of 250 mL or more of blood within 3 months prior to screening.
- •12. Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening.
- •13. Positive results from the HIV serology at screening.
- •14. Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- •15. Legal incapacity or limited legal capacity at screening.
- •16. History or clinical evidence of alcoholism or drug abuse.
- •17. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females). One unit is equivalent to a half-pint (220 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.
- •18. Individuals of Asian descent or other individuals reporting ethanol intolerance (Asian descent defined as 1 or more parents or grandparents of Asian origin).
- •19. Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy.
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