Befotertinib with Rifampicin or Itraconazole in Healthy People

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label, same-subject crossover Phase 1 trial in healthy adults. Two treatment groups will receive Befotertinib capsules alone with a subsequent coadministration of either rifampicin or itraconazole to assess drug-drug interactions. Participants will undergo a crossover design to compare pharmacokinetic profiles across conditions, with predefined dosing schedules for Befotertinib and the interacting drug. The study aims to understand how these common interacting medications may alter Befotertinib exposure in healthy individuals. Enrollment targets are 18 participants per group, with eligibility screening and safety monitoring throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.