A Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of HTL0009936 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events, as a measure of safety and tolerability
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in young and elderly healthy volunteers of HTL9936, a selective M1 receptor agonist intended for the treatment of cognitive disorders.
详细描述
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in young and elderly healthy volunteers of HTL9936, a selective M1 receptor agonist intended for the treatment of cognitive disorders. This study is a single ascending dose study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index of ≥19 and ≤ 30kg/m²
- •Healthy subject free from any clinically significant illness or disease
- •Female subjects must be ≥65 years
排除标准
- •Subject who is predicted to be a CYP2D6 poor or ultra rapid metabolizer
- •History of hypersensitivity to study drug
- •History of epilepsy or seizures
- •Subject with previous history of suicidal behavior
- •Subjects with significant hearing impairment
- •Subjects with an abnormal EEG
研究组 & 干预措施
HTL0009936
HTL0009936 single and multiple ascending oral doses.
干预措施: HTL0009936 (Drug)
HTL0009936 Placebo
HTL0009936 matching placebo
干预措施: HTL0009936 placebo (Drug)
结局指标
主要结局
Number of participants with Adverse Events, as a measure of safety and tolerability
时间窗: From signing of informed consent up to 30 days after the final visit
AE reports include a description of the AE, date and time of onset and resolution, intensity, and relationship to IMP.
Changes in vital signs as a measure of safety and tolerability
时间窗: Screening, Day-1, at select dosing days and at 5 to 7 days post dose for single dose, and 15 to 17 days post first dose in multiple dosing.
Pulse rate,body temperature,blood pressure, and orthostatic changes.
Changes in Safety Lab parameters as a measure of safety and tolerability
时间窗: Screening, Day-1, at select dosing days, and at 5 to 7 days post dose for single doseand 15 to 17 days post first dose in multiple dosing.
Hematology, clinical chemistry, urinalysis
Changes in 12-lead electrocardiograms as a measure of safety and tolerability
时间窗: Screening, pre-dose, at select dosing days and at 5 to 7 days post dose for single dose,and 15 to 17 days post first dose in multiple dosing.
Change in ECG parameters
次要结局
- Pharmacokinetic measures in cerebro spinal fluid (CSF) in young males as measured by max observed CSF (Cmax CSF)(Part 1 - 1h, 2h,3h post dose)
- Pharmacokinetic measures to assess the food effect as measured by ANOVA(Pre-dose, multiple time points to 24h, and at 12h, 24h and 5 to 7 days post dose.)
- Pharmacodynamic response as measured by pupillometry(Multiple time points Day1 to 6h post dose Part 1 only.)
- Pharmacokinetic measures in urine in young males and elderly male and female subjects as measured by amount of urine excreted at collection intervals(Pre-dose,multiple 4h collection intervals to 24h post dose on select dosing days to Day 10 for multiple dosing.)
- Pharmacodynamic response as measured by Bond and Lader visual analogue scale(Day 1 at multiple timepoints to 24h post dose.)
- Pharmacodynamic response as measured by changes in qEEG and Event Related Potentials (ERP)(Screening, Day-1, Day 4, Day 9 multiple dosing regimen only)
- Pharmacokinetic measures in plasma as measured by Peak plasma concentration (Cmax)(Pre-dose, multiple time points to 24h, at select dosing days, and 5 to 7 days post dosefor single dose,and 15 to 17 days post first dose in multiple dosing.)