DDI (Drug-Drug Interaction)
Conditions
Brief summary
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.
Interventions
DRUGBefotertinib 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.
DRUGBefotertinib 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.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax) | 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) | 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-∞) | From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group. |
Countries
China
Outcome results
None listed