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Drug-Drug Interaction Study of Befotertinib Capsules in Healthy Participants.

2026年9月3日 更新者:Betta Pharmaceuticals Co., Ltd.

A Single-Center, Open-Label, Same-Subject Sequential Crossover Clinical Trial to Evaluate the Effects of Rifampicin or Itraconazole on the Pharmacokinetics of Befotertinib Capsules in Healthy Participants

This study adopts a single-center, open-label, same-subject sequential crossover clinical trial design, aiming to evaluate the effects of oral administration of rifampicin or itraconazole on the pharmacokinetic profiles of Befotertinib capsules in healthy trial participants. The study consists of two treatment groups.

The rifampicin group is planned to enroll 18 healthy trial participants. Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 19 to Day 27 and Day29 to Day 40. On the morning of Day 28, participants will take Befotertinib capsules and rifampicin.

The itraconazole group is planned to enroll 18 healthy trial participants to evaluate the effect of itraconazole on the pharmacokinetic profiles of Befotertinib capsules. Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 19 to Day 21 and Day 23 to Day 32. On the morning of Day 22 participants will take Befotertinib capsulets and itraconazole.

研究概览

研究类型

介入性

注册 (估计的)

36

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

    • Zhejiang
      • Hangzhou、Zhejiang、中国、310052
        • 招聘中
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • 接触:

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:

  • 1. Body weight: ≥45 kg for females and ≥50 kg for males; body mass index (BMI) at screening ranging from 19 to 26 kg/m² (inclusive) [BMI = weight (kg)/height² (m²)];
  • 2. Results of examinations at screening and baseline (including physical examination, vital signs, laboratory tests: complete blood count, blood biochemistry, coagulation function, urinalysis, electrocardiogram, chest X-ray, etc.) are within normal limits, or abnormalities are present but judged by the investigator to have no clinical significance.

Exclusion Criteria:

  • 1. History of chronic systemic or severe diseases involving the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, musculoskeletal, hematopoietic or metabolic systems, particularly surgical conditions or illnesses that may affect drug absorption, distribution, metabolism and excretion;
  • 2. A personal or family history of long QT syndrome, or QTcF interval >450 ms in males and >470 ms in females; clinically significant ventricular arrhythmias and conduction blocks;
  • 3. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements within 14 days prior to screening;
  • 4. Special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeine-containing beverages) and inability to abstain during the trial; inability to accept standardized meals during hospitalization;
  • 5. Weekly alcohol intake of ≥14 alcohol units within 3 months before screening or positive breath alcohol test prior to enrolment; participants who cannot refrain from alcohol consumption throughout the study from signing the informed consent form until study completion.

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:其他
  • 分配:非随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:The rifampicin group
Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 19 to Day 27 and Day29 to Day 40. On the morning of Day 28, participants will take Befotertinib capsules and rifampicin.
Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 19 to Day 27 and Day29 to Day 40. On the morning of Day 28, participants will take Befotertinib capsules and rifampicin.
实验性的:The itraconazole group
Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 19 to Day 21 and Day 23 to Day 32. On the morning of Day 22 participants will take Befotertinib capsulets and itraconazole.
Participants will receive a single oral dose of Befotertinib capsules on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 19 to Day 21 and Day 23 to Day 32. On the morning of Day 22 participants will take Befotertinib capsulets and itraconazole.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Maximum plasma concentration (Cmax)
大体时间:From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.
From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
大体时间:From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.
From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.
Area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞)
大体时间:From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.
From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.

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。

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 (估计的)

2026年9月1日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年9月3日

首先提交符合 QC 标准的

2026年9月3日

首次发布 (实际的)

2026年9月9日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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