NL-OMON41910已完成不适用
Double-blind, placebo-controlled, randomized, single-ascending dose study to investigate the tolerability, safety, pharmacokinetics, pharmacodynamics, absolute bioavailability, mass balance, and metabolism of ACT-541468 in healthy male subjects - Safety and tolerability of ACT-541468
Actelion Pharmaceuticals0 个研究点目标入组 56 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
- 56
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
- •Signed informed consent in the local language prior to any study-mandated procedure.
- •Healthy male subjects aged between 18 and 45 years (inclusive) at screening.
- •Hematology, clinical chemistry, and urinalysis results not deviating from the normal range to a clinically relevant extent at screening.
- •No clinically significant findings on physical examination at screening.
- •Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
- •Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive) measured at screening on the dominant arm after 5 min in supine position.
- •12-lead ECG without clinically relevant abnormalities in supine position at screening.
- •Negative results from alcohol breath test and urine drug screen at screening and at Day 1.
- •Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
- •Only for subjects in the mass balance and metabolism part (third dose group): subjects must have a regular (daily) defecation pattern.
排除标准
- •Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- •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).
- •Treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St. John*s Wort) within 2 weeks prior to (first) study drug administration.
- •Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.
- •History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- •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 drugs (appendectomy and herniotomy allowed; cholecystectomy not allowed).
- •Excessive caffeine consumption, defined as >= 800 mg per day at screening.
- •Smoking within 3 months prior to screening and inability to refrain from smoking during the course of the study (from screening to EOS).
- •Loss of 250 ml or more of blood, or an equivalent amount of plasma, 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.
- •Known hypersensitivity to any excipients of the drug formulations.
- •Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy.
- •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.
- •Only for subjects in the mass balance and metabolism part (third dose group) or the absolute bioavailability part (fourth dose group): Radiation exposure, including that from the present study, excluding background radiation but including diagnostic rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed workers, as defined in the relevant Ionisation Radiation Regulations, must not participate in the study.
- •Participation in any study involving administration of any 14C-labeled compound within 12 months prior to screening.
- •For subjects in the mass balance and metabolism part (third dose group): Clinically relevant constipation (defined as lasting more than 3 days) in the 4-week period before screening.
研究者
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