A Study on the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of HMPL-760 Capsules
2026年9月17日 更新者：Hutchmed
An Open-Label, Randomized, Four-Period, Six-Sequence Phase I Study to Evaluate the Effect of Food and Proton Pump Inhibitor Rabeprazole on the Pharmacokinetics of HMPL-760 Capsules in Healthy Participants
This is a single-center, open-label, randomized, four-period, six-sequence study with a planned enrollment of 24 healthy participants.
The study consists of a screening period, a dosing period (Cycles 1, 2, 3, and 4), and a follow-up period.
Screening must occur within 14 days prior to the first dose of study drug.
Enrolled participants will be randomly assigned to one of 6 dosing sequences in the ratio of 1:1:1:1:1:1 to complete Cycles 1-3 dosing to evaluate the effect of different types of food on the PK of HMPL-760, and then to receive rabeprazole and HMPL-760 in Cycle 4 to assess the effect of PPI on the PK of HMPL-760 (see dosing sequence table for details).
研究概览
研究类型
介入性
注册 (实际的)
24
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200031
- Shanghai Xuhui Central Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Participants are fully aware of this study and voluntarily sign the ICF.
- Male or female aged 18 to 45 years old (inclusive).
- Participant's body mass index (BMI) at screening: 18 kg/m2 < BMI ≤ 29.9 kg/m2 and weight ≥ 50 kg for males and ≥ 45 kg for females.
- Participant is willing and able to comply with the protocol in all aspects.
Exclusion Criteria:
- Known history of any gastrointestinal surgery or any condition that could affect drug absorption (e.g., cholecystectomy, achlorhydria, peptic ulcer disease, gastric/intestinal surgery or history of resection; prior appendectomy or hernia repair is allowed).
- Clinically significant disease within 8 weeks prior to the first dose or clinically significant infection within 4 weeks prior to the first dose.
- Clinically significant abnormal findings in physical examination, vital signs, or laboratory tests at screening.
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at screening.
- Participants who smoked over 10 cigarettes daily within 3 months before screening.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Treatment A- HMPL-760
All participants in treatment A will fast overnight for at least 10 hours prior to HMPL-760 dosing.
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300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.
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实验性的：Treatment B- HMPL-760
All participants in treatment B will receive a standardized high-fat meal approximately 30 minutes before HMPL-760 administration
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300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.
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实验性的：Treatment C- HMPL-760
All participants in treatment C will receive a standardized low-fat meal approximately 30 minutes before HMPL-760 administration
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300 mg HMPL-760 will be administered orally once daily on Day 1, Day 6 and Day 11.
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实验性的：Treatment D- Rabeprazole and HMPL-760
All participants receive rabeprazole 20 mg orally QD(Quaque Die) 1 h before the breakfast on Day 15 and the morning of Day 16 to Day 20.
Rabeprazole and HMPL-760 are orally administered concomitantly under fasted conditions on the morning of Day 21.
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20 mg of rabeprazole will be administered orally once daily in the morning from Day 15 to Day 21, and a 300 mg oral dose of HMPL-760 will be administered concomitantly with rabeprazole on Day21.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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AUC 0-last
大体时间：Day 1 to Day 25
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Area under the plasma concentration-time curve from time zero to the last time point t where the concentration could be accurately determined
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Day 1 to Day 25
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AUC 0-inf
大体时间：Day 1 to Day 25
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Area under the plasma concentration-time curve from time 0 to infinity
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Day 1 to Day 25
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Cmax
大体时间：Day 1 to Day 25
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Maximum plasma concentration
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Day 1 to Day 25
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tmax
大体时间：Day 1 to Day 25
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Time to Cmax
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Day 1 to Day 25
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tlag
大体时间：Day 1 to Day 25
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Lag Time
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Day 1 to Day 25
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t1/2
大体时间：Day 1 to Day 25
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Terminal elimination half-life
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Day 1 to Day 25
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Adverse events rate
大体时间：Day 1 to Day 32(±1 day)
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Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
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Day 1 to Day 32(±1 day)
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Laboratory tests
大体时间：Day 1 to Day 32(±1 day)
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Number of participants with abnormal laboratory tests results
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Day 1 to Day 32(±1 day)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月30日
初级完成 (实际的)
2026年7月31日
研究完成 (实际的)
2026年8月31日
研究注册日期
首次提交
2026年6月8日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月11日
研究记录更新
最后更新发布 (实际的)
2026年9月18日
上次提交的符合 QC 标准的更新
2026年9月17日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.