A Phase I Clinical Study to Evaluate the Effect of Food on the Pharmacokinetics of HSK47388 Tablets in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE
研究概览
简要总结
This is a Phase 1, open-label, randomized, three-period crossover trial study to evaluate the effect of food and dosing and meal timing intervals on the pharmacokinetics (PK) of HSK46575 in healthy adult participants ,with an exploratory assessment of excretion pathways and excretion rates. Safety and tolerability will also be evaluated.
详细描述
The study consists of 3 treatment sequences in a 3-period, crossover design. Approximately 15 healthy adult participants will be randomized 1:1:1 to one of the following sequences:
Sequence A: Participants will receive HSK47388 orally in the fasted state (condition 1), administrate HSK47388 immediately after low-fat meal (condition 2), administrate HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3）.
Sequence B: Participants will receive administrate HSK47388 immediately after low-fat meal (condition 2), administrate HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3），HSK47388 orally in the fasted state (condition 1).
Sequence C: Participants will receive HSK47388 in the fasted state, followed by a standard meal speicific minutes later（condition 3),HSK47388 orally in the fasted state (condition 1), administrate HSK47388 immediately after low-fat meal (condition 2) .
All participants will remain under clinical observation for safety monitoring and pharmacokinetic sampling throughout each period. Blood, urine and fecal samples will be collected at defined intervals for the analysis of HSK47388 and its metabolites.
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
- None
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
- •Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- •Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.
- •Able and willing to attend the necessary visits to the study site
排除标准
- •Participants with any disease history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI.
- •Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol.
- •Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.
研究组 & 干预措施
fast
fast state
干预措施: fast (Dietary Supplement)
low fat meal
take HSK47388 with low fat meal
干预措施: low fat meal (Dietary Supplement)
take meal after HSK47388 administration
take meal after HSK47388 administration at specific time
干预措施: take meal after HSK47388 administration (Dietary Supplement)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE
时间窗: 5 days after every period dose
The incidence, severity, and relationship to IP of AEs. Change from Baseline in clinical laboratory parameters (ie, hematology, serum chemistry, coagulation, and urinalysis parameters), physical examination findings, vital signs
次要结局
- pharmacokinetics of HSK47388(time after 5 days in each period)
- culmulative excretion rate(5 days after dose in each period)