NL-OMON48154
已完成
不适用
A single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 4-way cross-over study to assess next-day driving performance following single and multiple evening administrations of ACT-541468 in middle-aged and elderly subjects. - Driving performance of ACT-541468
Idorsia Pharaceuticals Ltd.0 个研究点目标入组 56 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Idorsia Pharaceuticals Ltd.
- 入组人数
- 56
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Be male or female (of nonchildbearing potential) aged 50 to 80 years, inclusive, at the Screening Visit.
- •2\. Have a body mass index \*18\.5 and \*30\.0 kg/m2 at the Screening Visit.
- •3\. Be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety
- •tests, medical history, physical examination and vital sign measurements performed at the
- •screening visit and before the first dose of study drug.
排除标准
- •1\. Pregnant or lactating women.
- •2\. Known hypersensitivity to ACT\-541468, zopiclone, or treatments of the same class, or any of their excipients.
- •3\. Unstable medical condition, significant medical disorder, or acute illness within 2 months prior to Screening.
- •4\. Current heavy tobacco user (\* 15 cigarettes per day) or smoker with an urge to wake up during the night to smoke.
- •5\. No history of narcolepsy, cataplexy or fainting.
- •6\. Mini Mental State Examination (MMSE) score \< 25 at Screening.
- •7\. Current or previous diagnosis of insomnia\-related disorder according to the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM\-5\) criteria.
- •8\. Modified Swiss Narcolepsy Scale total score \< 0 at Screening.
- •9\. Activities that disturb the circadian rhythm (e.g., working night shift, travelling across 3 time zones) within 2 weeks before (each) study treatment.
结局指标
主要结局
未指定
相似试验
已完成
不适用
A single-center, randomized, double-blind, two-period cross-over study to investigate the effect of a single intravenous dose of rifampicin on the pharmacokinetics of ACT-246475 in healthy subjects.NL-OMON46064Idorsia Pharmaceuticals Ltd14
已完成
不适用
A single-center, randomized, double-blind, two-period cross-over study to investigate the effect of rifampicin on the pharmacokinetics of clazosentan in healthy male subjects.NL-OMON45870Idorsia Pharmaceuticals Ltd14
进行中（未招募）
不适用
Study to determine the pH produced in the stomach and oesophagus after taking Gaviscon Double Action Liquid Vs Placebo.To pilot the use of a novel pH catheter for the measurement of oesophageal and intragastric pH comparing the onset and duration of antacid action of Gaviscon Double Action versus placebo.Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]EUCTR2011-004725-27-GBReckitt Benckiser Healthcare (UK) Ltd
尚未招募
1 期
A Phase I clinical trial to study the effect of two drugs, Insulin Glargine manufactured by BioGenomics limited and Lantus® by comparing pharmacokinetic and pharmacodynamic properties, safety and tolerability in healthy male volunteers.CTRI/2022/09/045313BioGenomics Ltd
招募中
1 期
Phase-I clinical trial of Stelis Insulin Glargine injection 100IU/mL in healthy adultsCTRI/2020/12/030079Stelis Biopharma Pvt Ltd