NL-OMON45722已完成不适用
A single-center, double-blind, placebo-controlled, randomized study to investigate the tolerability, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-dose ACT-541468 in healthy Japanese and Caucasian subjects. - AC-078-105
Actelion Pharmaceuticals0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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 64（—）
入选标准
- •- Signed informed consent prior to any study-mandated procedure.
- •- Healthy male and female subjects aged between 20 and 50 years (inclusive) at screening.
- •- A woman of childbearing potential must provide:
- •- Negative serum pregnancy test at screening.
- •- Negative urine pregnancy test at Day 1.
- •- Agreement to undertake pregnancy tests up to 30 days after EOT.
- •- No clinically significant findings on the physical examination at screening.
- •- Body mass index of 18.0 to 26.0 kg/m2 (inclusive) at screening.
- •- Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on either arm, after 5 min in the supine position at screening and at Day 1 pre dose.
- •- 12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 min in the supine position at screening and at Day 1 pre-dose.
- •- Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
- •- Negative results from urine drug screen and alcohol breath test at screening and Day 1.
- •- Ability to communicate well with the investigator, in the local language (Dutch, English, or Japanese), and to understand and comply with the requirements of the study.
- •- Subjects must be of Caucasian or Japanese ethnicity.;Japanese subjects only:
- •- Subjects must be of native Japanese descent (all parents/grandparents of Japanese descent).
- •* Subjects must not have been away from Japan for more than 10 years (at screening visit).
- •* Subject's lifestyle should not have changed significantly since relocation from Japan.
排除标准
- •- Known hypersensitivity to ACT-541468 or drugs of the same class, or any of the excipients.
- •- Previous exposure to the study drug.
- •- Known hypersensitivity or allergy to natural rubber latex.
- •- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- •- Previous relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- •- Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy.
- •- Veins unsuitable for 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).
- •- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- •- Excessive caffeine consumption, defined as > 800 mg per day at screening.
- •- 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).
- •- Treatment with another investigational treatment within 3 months prior to screening or participation in more than 4 investigational treatment studies within 1 year prior to screening.
- •- Previous treatment with any prescribed medications (including all type of vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John*s Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks or 5 half-lives (whichever is longer) prior to first study treatment administration.
- •- Loss of 250 mL or more of blood within 3 months prior to screening.
- •- Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening.
- •- Positive results from the HIV serology at screening.
- •- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- •- Legal incapacity or limited legal capacity at screening.
研究者
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