Drug Interaction ResearchPhase 1NCT07768111
Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets
A Phase 1 study testing 75mg Flonoltinib and 100mg Flonoltinib in people with Drug Interaction Research, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 1 site in China.
Trial summary
This study is a single center, open label, fixed sequence drug interaction study to evaluate the effects of CYP3A4 inhibitor itraconazole and CYP3A4 inducer rifampicin on the pharmacokinetic characteristics of a single oral dose of flonotinib maleate tablets. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction Research
- What is being tested?
- 75mg Flonoltinib and 100mg Flonoltinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2026to 31 Jan 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
- Chinese healthy adult , aged 18-45 years old
- During the screening period, participants male weight >=50.0 kg, female weight >=45.0 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
Who cannot join
- Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR ^ 0.33)) corrected QT interval (QTcF)>450 milliseconds
- HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test
- Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results
- Individuals who have consumed any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in
- Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection
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
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Zhang Jing, +86 551-63806061, aydefyllwyhbgs@163.com
About this study
Official title: A Single-Center, Open, Fixed-Sequence Clinical Drug Interaction Study Evaluating the Effects of Itraconazole or Rifampicin on the Pharmacokinetic Profile of Flonoltinib Maleate Tablets in Healthy Participants
This study is a single center, open label, fixed sequence drug interaction study to evaluate the effects of CYP3A4 inhibitor itraconazole and CYP3A4 inducer rifampicin on the pharmacokinetic characteristics of a single oral dose of flonotinib maleate tablets.
This trial includes screening period, baseline period, medication observation period, and follow-up period, totaling approximately 3 months.
- Conditions
- Drug Interaction Research
- Being tested
- 75mg Flonoltinib, 100mg Flonoltinib
- Keywords
- FM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75mg FlonoltinibDrug
Day 1 and Day 12 : 75mg Flonoltinib on an empty stomach in the morning
100mg FlonoltinibDrug
Day 1 and Day 19 : 100mg Flonoltinib on an empty stomach in the morning
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: 75mg Flonoltinib |
| Part B | Experimental | Not described Receives: Drug: 100mg Flonoltinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: Until 144hours
Tmax
Measured: Until 144hours
AUC0-t
Measured: Until 144hours
t1/2
Measured: Until 144hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Interaction ResearchStudies of the same condition, open and under way.
- More trials run by Chengdu Zenitar Biomedical Technology Co., LtdThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768111
- Sponsor's protocol ID
- FM-DDI
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open, Fixed-Sequence Clinical Drug Interaction Study Evaluating the Effects of Itraconazole or Rifampicin on the Pharmacokinetic Profile of Flonoltinib Maleate Tablets in Healthy Participants
- ClinicalTrials.gov ID
- NCT07768111
- Acronym / sponsor ID
- FM-DDI
- Conditions
- Drug Interaction Research
- Keywords
- FM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 17 Aug 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 is a single center, open label, fixed sequence drug interaction study to evaluate the effects of CYP3A4 inhibitor itraconazole and CYP3A4 inducer rifampicin on the pharmacokinetic characteristics of a single oral dose of flonotinib maleate tablets.
This trial includes screening period, baseline period, medication observation period, and follow-up period, totaling approximately 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: 75mg Flonoltinib |
| Part B | Experimental | Drug: 100mg Flonoltinib |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese healthy adult , aged 18-45 years old
- During the screening period, participants male weight >=50.0 kg, female weight >=45.0 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
Key exclusion criteria (5 listed)
- Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR ^ 0.33)) corrected QT interval (QTcF)>450 milliseconds
- HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test
- Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results
- Individuals who have consumed any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in
- Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection
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 |
|---|---|---|
| 75mg FlonoltinibDay 1 and Day 12 : 75mg Flonoltinib on an empty stomach in the morning | Drug | Part A |
| 100mg FlonoltinibDay 1 and Day 19 : 100mg Flonoltinib on an empty stomach in the morning | Drug | Part B |
Primary outcome
Cmax
Time frame: Until 144hours
Tmax
Time frame: Until 144hours
AUC0-t
Time frame: Until 144hours
t1/2
Time frame: Until 144hours
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 19 Aug 2026.
Related trials for Drug Interaction Research
RecruitingObservational study
Pediatric Research in the Outpatient Setting CoHort
Parental Stress, Communication Disorder, Childhood
Recruiting
Dino Study: Daily Intervention-based Research on Nurturing Opportunities in Young Children
Behavior Problems in Children, Parent-Child Relations
RecruitingPhase 1
A Study of Navlimetostat (BMS-986504) Drug Interactions and Food Effect in Healthy Participants
Healthy Female Adults
Recruiting
Health Ahead Comparative Effectiveness Study
Health Services Accessibility, Rural Health
Not yet recruitingObservational study
Research Project on the Interaction Between Immune Function and Infectious Diseases in Older Adults and the Development of Prevention and Control Strategies
Infectious Diseases, Immunosenescence
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.
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 75mg Flonoltinib and 100mg Flonoltinib in people with Drug Interaction Research, run by Chengdu Zenitar Biomedical Technology 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 3 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: opening soon, as of the sponsor's last update on 19 Aug 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?
Contact Wang Fangmei (+8613808086495, fangmei.wang@zenitar.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Until 144hours). The study lists 4 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 19 Aug 2026.