Health TrialsbyHealthPanel

Drug-Drug Interaction Study of Befotertinib Capsules 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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

  • Befotertinib and rifampicin

    Drug

    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.

  • Befotertinib and itraconazole

    Drug

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group 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 312 hours post-dose in rifampicin group. From pre-dose to 384 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 312 hours post-dose in rifampicin group. From pre-dose to 384 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 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Betta Pharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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