NL-OMON42430已完成不适用
Double-blind, placebo-controlled, randomized study to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-541468: Part A: Multiple-ascending doses in healthy young adults after morning administration. Part B: Single-ascending doses in healthy elderly subjects after morning administration. Part C: Repeated doses in both healthy young adults and elderly subjects after evening administration. - Tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-541468
Actelion Pharmaceuticals0 个研究点目标入组 84 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
- 84
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 and female subjects aged between 18 and 45 years (inclusive) at screening.
- •- Elderly (part B and C only): Healthy male and female subjects aged between 65 and 80 years (inclusive) at screening.
- •- Subjects must have a regular sleep pattern of at least 6 hours nocturnal sleep.
- •- Women must have a negative serum pregnancy test at screening and a negative urine pregnancy test predose on Day 1. Women of childbearing potential must consistently and correctly use (from screening, during the entire study, and for at least 90 days after last study drug intake) a reliable method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner. (Details about reliable contraceptive measures only to be given in the core protocol (not in the protocol outline)).
- •- No clinically significant findings on the physical examination at screening.
- •- Body mass index (BMI) of 18.0 to 30.0 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 the dominant arm, after 5 min in the supine position at screening.
- •- Elderly: SBP 100-160 mmHg, diastolic blood pressure (DBP) 50-95 mmHg, and pulse rate 45-100 bpm (inclusive), measured on the dominant arm, after 5 min in the supine position at screening.
- •- 12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 min in the supine position at screening.
- •- Hematology, coagulation, 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 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
- •- Pregnant or lactating women.
- •- Known hypersensitivity to the drug or drugs of the same class, or any of their excipients of the drug formulation.
- •- Previous exposure to the study medication.
- •- 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 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 End-of-Study [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.
- •- 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.;Elderly only:
- •- Previous chronic treatment with any medication that is not given in stable doses and/or stable regimen within 2 months prior to screening.
- •- Previous treatment with central nervous system (CNS)-active drugs within 2 months prior to screening.
- •- Treatment with inhibitors of cytochrome P450 (CYP) 3A4 (e.g., azole derivatives, ritonavir, clarithromycin) from 2 weeks prior to screening visit and up to EOS.
研究者
相似试验
进行中（未招募）
不适用
Double-blind, placebo controlled, randomized study of vardenafil to determine efficacy on Erectile Dysfunction (ED) in men with ED and Metabolic Syndrome (ED-METABOLIC) - ED-METABOLICThe objective of this study is to determine efficacy, tolerability and safety of vardenafil on Erectile Dysfunction (ED) in men with ED and Metabolic Syndrome.EUCTR2008-002140-41-DEBayer HealthCare AG180
进行中（未招募）
1 期
Efficacy, safety, and tolerability of Ancrod in patients with sudden hearing losssudden sensorineural hearing loss (SSHL)MedDRA version: 20.0Level: LLTClassification code 10040016Term: Sensorineural hearing lossSystem Organ Class: 100000013775EUCTR2012-000066-37-CZordmark Arzneimittel GmbH & Co. KG115
进行中（未招募）
1 期
Efficacy, safety, and tolerability of Ancrod in patients with sudden hearing losssudden sensorineural hearing loss (SSHL)MedDRA version: 20.0Level: LLTClassification code 10040016Term: Sensorineural hearing lossSystem Organ Class: 100000004854EUCTR2012-000066-37-DEordmark Arzneimittel GmbH & Co. KG115
招募中
3 期
Activity of Curcumin derivative on Joint Inflammation (knees) of the patients.CTRI/2023/09/058104Sam Sabinsa Group Limited
Unknown
1 期
Clinical study to assess safety and efficacy related to the use of donor stem cells in the treatment of COVID-19.RBR-65trt53R-Crio Criogenia S.A.