A Double-blind, Placebo-controlled Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Administration of XEN1101 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events (AEs) as assessed by CTCAE v4.03
研究概览
简要总结
The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will eventuate the safety, tolerability, pharmacokinetics (PK) and effects on transcranial magnetic stimulation (TMS) of oral doses of XEN1101 in healthy male subjects.The TMS procedure is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or EMG activity. It is estimated there will be approximately 15 subjects in the planned study.
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
- Triple (Participant, Care Provider, 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 aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 30.0 kg/m2
- •Right-handed only
- •Must agree to use effective methods of contraception, if applicable
- •Able to swallow multiple capsules
- •Able to provide written, personally signed and dated Informed Consent Form
排除标准
- •Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject's ability to participate in the study
- •Any clinically significant abnormalities in vital signs, ECGs, physical examinations, or laboratory evaluations
- •Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale Mental incapacity or language barriers precluding adequate understanding, cooperation, and compliance with the study
- •No prescription or over-the-counter (OTC) medications (including multivitamins, herbal or homeopathic preparations 14 days or if applicable/available, 5 half-lives prior to dosing to study end
- •Any history of severe head trauma
- •No smoking 60 days prior to dosing to study end
研究组 & 干预措施
XPF-008
Single oral dose
干预措施: XPF-008 (Drug)
Placebo
Single oral dose
干预措施: Microcrystalline Cellulose (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs) as assessed by CTCAE v4.03
时间窗: From screening (28 days prior to Day 1) through to 30 days post-final dose
To assess AEs as a criteria of safety and tolerability
Resting 12-lead electrocardiogram (ECG)
时间窗: From screening (28 days prior to Day 1) through to Day 14
To assess ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability
Number of participants with vital sign abnormalities
时间窗: From screening (28 days prior to Day 1) through to Day 14
To assess vital signs as a criteria of safety and tolerability
Pharmacodynamic (PD) Effects assessed by Transcranial Magnetic Stimulation (TMS) biological markers of brain excitability
时间窗: Day 1 predose through to Day 7
To assess biological marker of brain excitability: amplitude (in uV) of TMS evoked potentials on the EEG
PD Effects assessed by TMS biological markers of brain excitability
时间窗: Day 1 predose through to Day 7
To assess biological marker of brain excitability: resting motor threshold (in %) for elicitation of an electromyographic response
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Day 1 predose through to Day 8)
- Terminal elimination half-life (t1/2)(Day 1 predose through to Day 8)
- Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last)(Day 1 predose through to Day 8)