NL-OMON32097尚未招募不适用
A single-center, randomized, placebo-controlled, two-way crossover study to investigate the drug-drug interaction on the pharmacokinetics and pharmacodynamics of ACT-078573 and single-dose desipramine in healthy male subjects - Study to investigate the interaction of ACT-078573 and desipramine
Actelion Pharmaceuticals0 个研究点目标入组 20 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
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Signed informed consent prior to any study-mandated procedure.;Male aged between 18 and 45 years (inclusive) at screening.;CYP2D6 extensive metabolizer (EM) genotype.;No clinically significant findings on the physical examination at screening.;Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) at screening.;Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP)
- •50-90 mmHg, and heart rate (HR) 45-90 bpm (all inclusive), measured at screening on the leading arm after 5 minutes in the supine position.;12-lead electrocardiogram (ECG) without clinically relevant abnormalities at screening and meeting the following criteria: QTcB interval * 430 msec, QRS interval * 110 msec, and PR interval * 220 msec.;Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening.;Negative results from urine drug screen at screening.;Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
排除标准
- •History of cardiovascular disease (e.g., arrhythmia, congenital long QT syndrome).;History of seizures disorders.;Clinically significant findings at baseline assessments for pupillometry.;Any contraindication to desipramine or any tricyclic antidepressant (TCA).;Known hypersensitivity to desipramine, or any TCA, Ponceau 4R, or any other excipients of the drug formulations.;Treatment with any prescribed or OTC medications (including herbal medicines such as St John*s Wort) within 2 weeks prior to screening.;Treatment with another investigational drug within 3 months prior to screening or more than 4 times within the year prior to screening.;History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.;Excessive caffeine consumption (more than 800 mg per day) at 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.;Smoking within 3 months prior to screening and inability to refrain from smoking during the course of study.;Loss of 250 mL or more of blood within 3 months prior to screening.;Positive hepatitis serology, except for vaccinated subjects, at screening.;Positive 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
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