NCT04966832已完成1 期
A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults
XWPharma1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年7月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Incidence, severity, and causality of adverse events (AEs)
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of XW10508 in healthy volunteers.
详细描述
This is a first-in-human single and multiple ascending oral dose pharmacokinetic and safety study where participants will receive either XW10508 or placebo. Both immediate release and modified release formulations will be assessed. Timed blood samples will be collected to assess the pharmacokinetics after the study drug is ingested by the participants.
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
- Double (Participant, 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 female participants who are 18 to 55 years of age, inclusive.
- •Participant is willing and able to provide signed and dated written informed consent to participate prior to admission to the study.
排除标准
- •Evidence or history of clinically significant (in the opinion of the investigator) gastrointestinal, hepatic, renal, respiratory (e.g., asthma, COPD), cardiovascular (e.g., hypertension), metabolic, psychiatric, neurological, immunological, or endocrine disorders, or allergic disease including drug allergies, including immediate type hypersensitivity to components of the study drug. A history of childhood asthma that has resolved is acceptable.
- •Use of tobacco- or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches, vaping device, etc.) within 3 months prior to Day -1 and/or positive urine cotinine test at Screening or Day -
- •Participant who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, pharmacokinetics or pharmacodynamics of the investigational drug; or is unable to comply with the study protocol.
研究组 & 干预措施
XW10508
Experimental
XW10508 capsules or tablets
干预措施: XW10508 (Drug)
Placebo
Placebo Comparator
Placebo capsules or tablets
干预措施: Placebo (Other)
结局指标
主要结局
Incidence, severity, and causality of adverse events (AEs)
时间窗: Up to 12 Days
次要结局
- AUC over the dosing interval (AUCtau)(48 hours)
- Cmax and AUC ratios of metabolites to XW10172(48 hours)
- Time to reach Cmax (Tmax)(48 hours)
- Maximum concentration (Cmax)(48 hours)
- Trough concentration (Cmin)(48 hours)
- Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration(48 hours)
- Apparent terminal half-life (t1/2)(48 hours)
- AUC from time 0 extrapolated to infinity (AUC0-inf)(48 hours)
研究者
研究点 (1)
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