Drug-Drug Interaction Study of Vorolanib Tablets in Healthy Participants
ConditionDDI (Drug-Drug Interaction)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBetta Pharmaceuticals Co., Ltd.
About this trial
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 vorolanib tablets 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 vorolanib tablets on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 6 to Day 17. On the morning of Day 15, participants will take vorolanib tablets and rifampicin.
The itraconazole group is planned to enroll 18 healthy trial participants to evaluate the effect of itraconazole on the pharmacokinetic profiles of vorolanib tablets. Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 6 to Day 13. On the morning of Day 9, participants will take vorolanib tablets and itraconazole.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Crossover
Treatments tested in this trial
vorolanib and rifampicin
DrugParticipants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 6 to Day 17. On the morning of Day 15, participants will take vorolanib tablets and rifampicin.
vorolanib and itraconazole
DrugParticipants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 6 to Day 13. On the morning of Day 9, participants will take vorolanib tablets and itraconazole.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: The rifampicin groupExperimental treatment 1 intervention
Group B: The itraconazole groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum plasma concentration (Cmax)
Time frame
From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.2
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
Time frame
From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.3
Area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞)
Time frame
From pre-dose to 72 hours post-dose in rifampicin group. From pre-dose to 120 hours post-dose in itraconazole group.Sponsors and contacts
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Source ClinicalTrials.gov