A Double-Blind, Placebo Controlled, Randomized, Adaptive, First-in-Human Study to Assess, Safety, Tolerability, Pharmacokinetics and Food Effect of Single and Multiple Doses of BLU-5937 Administered Orally in Healthy Male and Female
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number and severity of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 using a double blind, placebo controlled, randomized, adaptive, single center study design. The influence of food on the pharmacokinetics of BLU-5037 will also be investigated.
详细描述
BLU-5937 is a selective P2X3 receptor antagonist being developed for the treatment of chronic cough. This Phase 1 study will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 administered orally to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male and/or female (non-childbearing potential or, for women of childbearing potential, using 2 forms of acceptable birth control or agreed to abide by true abstinence),
- •Age: 18 to 55 years (inclusive).
- •Body mass index (BMI) : ≥18.5 and ≤30 kg/m².
- •Non or ex smoker.
排除标准
- •Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) outside from normal and deemed by the investigator to be clinically significant.
- •Use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy.
- •Volunteers who took an Investigational Product in the 28 days prior to the first study drug administration.
- •Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration.
- •Donation of 500 mL or more of blood in the 56 days prior to the first study drug administration.
研究组 & 干预措施
Single Ascending Doses
Single ascending doses, 6 dose levels
干预措施: BLU-5937 (Drug)
Single Ascending Doses
Single ascending doses, 6 dose levels
干预措施: Placebo (Drug)
Multiple Ascending Doses
Multiple ascending doses, 3 dose levels
干预措施: BLU-5937 (Drug)
Multiple Ascending Doses
Multiple ascending doses, 3 dose levels
干预措施: Placebo (Drug)
结局指标
主要结局
Number and severity of treatment emergent adverse events (TEAEs)
时间窗: up to 48 hours after the last dose
Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose
次要结局
- Area under the curve (AUC) under fed conditions(up to 48 hours after the last dose)
- Maximum plasma concentration (Cmax)(up to 48 hours after the last dose)
- Area under the curve (AUC)(up to 48 hours after the last dose)
- Maximum plasma concentration (Cmax) under fed conditions(up to 48 hours after the last dose)