Phase 1, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 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 XEN901 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and pharmacokinetics (PK) of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN901 in healthy subjects. It is estimated there will be approximately 64 subjects in the planned SAD and MAD cohorts.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.5 and 32.0 kg/m2
- •Must agree to use effective methods of contraception, if applicable
- •Able to swallow capsules
- •Able to provide written, personally signed and dated Informed Consent Form
排除标准
- •Any history of seizures
- •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
- •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 (except hormonal contraception), herbal or dietary supplements OTC medications 14 days prior to dosing to study end
- •No smoking 60 days prior to dosing to study end
- •Any clinically significant abnormalities in vital signs, ECG, physical exam, or laboratory evaluations
研究组 & 干预措施
XEN901
Single ascending dose: Single oral dose for each cohort; Multiple ascending dose: 7 days of single oral dose twice daily for each cohort
干预措施: XEN901 (Drug)
Placebo
Single Ascending Dose: Single oral dose for each cohort; Multiple Ascending Dose: 7 days of single oral dose twice daily for each cohort
干预措施: Inert Ingredients Oral Product (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: At screening (28 days prior to Day 1) through to 7 days post-final dose
To assess 12-lead ECG intervals (PR, QRS, QTcF, RR) as a criteria of safety and tolerability
Number of participants with vital sign abnormalities
时间窗: At screening (28 days prior to Day 1) through to 7 days post-final dose
To assess vital signs as a criteria of safety and tolerability
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Day 1 predose through to 7 days post-final dose)
- Time to the Maximum Observed Plasma Concentration (Tmax)(Day 1 predose through to 7 days post-final dose)
- Terminal elimination half-life (t1/2)(Day 1 predose through to 7 days post-final dose)
- 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 7 days post-final dose)