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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Hutchmed
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Rabeprazole and HMPL-760 (Drug)
Treatment A- HMPL-760
All participants in treatment A will fast overnight for at least 10 hours prior to HMPL-760 dosing.
干预措施: HMPL-760 (Drug)
Treatment B- HMPL-760
All participants in treatment B will receive a standardized high-fat meal approximately 30 minutes before HMPL-760 administration
干预措施: HMPL-760 (Drug)
Treatment C- HMPL-760
All participants in treatment C will receive a standardized low-fat meal approximately 30 minutes before HMPL-760 administration
干预措施: HMPL-760 (Drug)