A Randomized, Placebo Controlled, Double-blind, Double-dummy, Three-way Crossover Trial to Investigate the Effect of Two Doses of BI 474121 on Ketamine Induced Cognitive Deficits in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Difference between the total number of errors adjusted for stages that subjects did not complete in the paired associate learning test (PALTEA28), post-ketamine minus the PALTEA28 pre-ketamine
研究概览
简要总结
To investigate the effect of BI 474121 compared to placebo on ketamine-induced cognitive deficits to predict efficacy in patients with cognitive disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 55 years (inclusive)
- •Body mass index (BMI) of 18.5 to 32 kg/m2 (inclusive)
- •Signed and dated written informed consent(s) prior to admission to the study, in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •If men who are able to father a child, are willing to participate, they have to use an adequate form of effective contraception for the duration of study participation and for at least 30 days after treatment has ended
排除标准
- •Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm evaluated as clinically significant by Investigators
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- •History of diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- •History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
研究组 & 干预措施
Treatment sequence R-T1-T2
干预措施: Placebo (Drug)
Treatment sequence R-T1-T2
干预措施: BI 474121 (Drug)
Treatment sequence T1-T2-R
T1: Lower dose of BI 474121 and higher dose of placebo followed by intravenous ketamine infusion T2: Higher dose of BI 474121 and lower dose of placebo followed by intravenous ketamine infusion R: Lower dose of placebo and higher dose of placebo followed by intravenous ketamine infusion
干预措施: BI 474121 (Drug)
Treatment sequence T1-T2-R
T1: Lower dose of BI 474121 and higher dose of placebo followed by intravenous ketamine infusion T2: Higher dose of BI 474121 and lower dose of placebo followed by intravenous ketamine infusion R: Lower dose of placebo and higher dose of placebo followed by intravenous ketamine infusion
干预措施: Placebo (Drug)
Treatment sequence T1-T2-R
T1: Lower dose of BI 474121 and higher dose of placebo followed by intravenous ketamine infusion T2: Higher dose of BI 474121 and lower dose of placebo followed by intravenous ketamine infusion R: Lower dose of placebo and higher dose of placebo followed by intravenous ketamine infusion
干预措施: Ketamine hydrochloride (Drug)
Treatment sequence T2-T1-R
干预措施: BI 474121 (Drug)
Treatment sequence T2-T1-R
干预措施: Placebo (Drug)
Treatment sequence T2-T1-R
干预措施: Ketamine hydrochloride (Drug)
Treatment sequence T1-R-T2
干预措施: BI 474121 (Drug)
Treatment sequence T1-R-T2
干预措施: Placebo (Drug)
Treatment sequence T1-R-T2
干预措施: Ketamine hydrochloride (Drug)
Treatment sequence T2-R-T1
干预措施: BI 474121 (Drug)
Treatment sequence T2-R-T1
干预措施: Placebo (Drug)
Treatment sequence T2-R-T1
干预措施: Ketamine hydrochloride (Drug)
Treatment sequence R-T1-T2
干预措施: Ketamine hydrochloride (Drug)
Treatment sequence R-T2-T1
干预措施: BI 474121 (Drug)
Treatment sequence R-T2-T1
干预措施: Placebo (Drug)
Treatment sequence R-T2-T1
干预措施: Ketamine hydrochloride (Drug)
结局指标
主要结局
Difference between the total number of errors adjusted for stages that subjects did not complete in the paired associate learning test (PALTEA28), post-ketamine minus the PALTEA28 pre-ketamine
时间窗: up to 22 days
次要结局
- Difference between the Rapid Visual Information Processing test A' (RVPA), post-ketamine minus the RVPA pre-ketamine(up to 22 days)
- Difference between the between errors in the spatial working memory test (SWMBE468), post-ketamine minus the SWMBE468 pre-ketamine(up to 22 days)