DDI (Drug-Drug Interaction)Phase 1NCT07809815
Drug-Drug Interaction Study of Befotertinib Capsules in Healthy Participants.
A Phase 1 study testing Befotertinib and rifampicin and Befotertinib and itraconazole in people with DDI (Drug-Drug Interaction), run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- DDI (Drug-Drug Interaction)
- What is being tested?
- Befotertinib and rifampicin and Befotertinib and itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Bo Jiang, 86-0571-87315215, jiangbo@zju.ed
About this study
Official title: A Single-Center, Open-Label, Same-Subject Sequential Crossover Clinical Trial to Evaluate the Effects of Rifampicin or Itraconazole on the Pharmacokinetics of Befotertinib Capsules in Healthy Participants
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.
- Conditions
- DDI (Drug-Drug Interaction)
- Being tested
- Befotertinib and rifampicin, Befotertinib and itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Befotertinib and rifampicinDrug
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 itraconazoleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| The rifampicin group | Experimental | 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. Receives: Drug: Befotertinib and rifampicin |
| The itraconazole group | Experimental | 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. Receives: Drug: Befotertinib and itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: 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)
Measured: 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-∞)
Measured: From pre-dose to 312 hours post-dose in rifampicin group. From pre-dose to 384 hours post-dose in itraconazole group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DDI (Drug-Drug Interaction)Studies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809815
- Sponsor's protocol ID
- IBIO-106
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Same-Subject Sequential Crossover Clinical Trial to Evaluate the Effects of Rifampicin or Itraconazole on the Pharmacokinetics of Befotertinib Capsules in Healthy Participants
- ClinicalTrials.gov ID
- NCT07809815
- Acronym / sponsor ID
- IBIO-106
- Conditions
- DDI (Drug-Drug Interaction)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The rifampicin group | Experimental | Drug: Befotertinib and rifampicinParticipants 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 | Experimental | Drug: Befotertinib and itraconazoleParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Befotertinib and rifampicinParticipants 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. | Drug | The rifampicin group |
| Befotertinib and itraconazoleParticipants 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. | Drug | The itraconazole group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Befotertinib and rifampicin and Befotertinib and itraconazole in people with DDI (Drug-Drug Interaction), run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.