Vorolanib Drug-Drug Interaction Test with Rifampicin or Itraconazole

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, two-sequence crossover study in healthy volunteers designed to examine how common interacting drugs alter vorolanib pharmacokinetics. Participants receive vorolanib alone and then coadministration with either rifampicin or itraconazole in separate groups, with sequential dosing over a 2- to 3-week period. The rifampicin group enrolls 18 participants who take vorolanib on Day 1 and then rifampicin daily from Day 6 to Day 17, with a combined dose on Day 15; the itraconazole group enrolls 18 participants with a similar setup to assess itraconazole effects. The study focuses on identifying potential changes in vorolanib exposure due to drug-drug interactions in a healthy population.

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.