TumorPhase 1NCT05041920
A Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects
A Phase 1 study testing famitinib、omeprazole in people with Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective is to evaluate the effect of omeprazole on the pharmacokinetics of famitinib malate in healthy adult subjects. The secondary objective is to evaluate the safety after famitinib malate alone or combined administration with omeprazole in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor
- What is being tested?
- famitinib、omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2021to 27 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Participants should sign the informed consent before the study, and fully understand the content, process and possible adverse reactions of the study;
- Capable to complete the study according to the requirements of study protocol;
- Healthy male and female subjects aged between 18 and 45 (inclusive) at the time of signing the informed consent, of which no less than 1/3 are female subjects;
- Participants should have no fertility plan from signing the informed consent until 6 months after the last medication, take effective contraceptive measures voluntarily and have no sperm donation plan. The serum HCG test of fertile women must be negative before Screening;
- Body weight ≥ 50.0 kg for men and body weight ≥ 45.0 kg for women, and body mass index (BMI) within the range of 19.0 to 28.0 kg /m2 (inclusive);
- Creatinine clearance (CLCr) ≥80 mL/min, and creatinine is less than or equal to the upper limit of normal value.
Who cannot join
- Those who donated blood or suffered blood loss ≥400 mL within 3 months prior to Screening, donated blood or suffered blood loss ≥200 mL within 1 month prior to Screening, or received blood transfusion;
- Allergic constitution, including a history of severe drug/food allergy; Any history of allergy to famitinib malate capsules or omeprazole magnesium enteric-coated tablets;
- Any history of drug abuse, positive results for alcohol, nicotine or drugs at Screening;
- Those who have heavy smokers and alcoholic will not be able to prohibit smoking and alcohol during the trial;
- Any history of dysphagia or any gastrointestinal disease that affects drug absorption;
- Those who have any uncontrolled peptic ulcer, colitis, pancreatitis, etc.;
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- Those who have received any operation within 6 months before Screening; Previous surgery affecting gastrointestinal absorption (including gastrectomy, intestinal resection, gastric contraction surgery, etc.);
- Subjects with any clinically significant acute disease occurring within 1 month prior to Screening;
- QTcF>470 msec for women or >450 msec for men;
- Any pre-existing chronic or severe medical history of nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism, and musculoskeletal system;
- Participation in any clinical trial within 3 months before Screening;
- Those who took any other drugs that affect liver metabolism within 28 days prior to taking the investigational drug;
- Those who took any prescription or non-prescription drugs, any vitamin products or herbal medicine within 14 days prior to receiving the investigational drug;
- Abnormal vital signs at Screening;
- Clinical laboratory tests, infectious disease screening, 12-lead electrocardiogram, abdominal B ultrasound, X-ray or CT examination with abnormalities and clinical significance;
- Consumption of grapefruit or grapefruit products, caffeine, or xanthine foods or beverages within 48 hours prior to taking the investigational drug; Strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.;
- Lactating women;
- History of injection needle or blood fainting, those who have difficulty in blood collection or cannot tolerate venepuncture blood collection; Those who cannot accept a uniform diet;
- Subjects with other factors unsuitable to participate in the study considered by the researcher or subjects withdraw from the study due to their own reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongda Hospital, Affiliated to Southest University
Nanjing, Jiangsu, 210009
About this study
Official title: A Single-centre, Single-arm, Open-label and Fixed-sequence Study to Evaluate the Effect of Omeprazole on Pharmacokinetics of Famitinib Malate in Healthy Adult Subjects
The primary objective is to evaluate the effect of omeprazole on the pharmacokinetics of famitinib malate in healthy adult subjects.
The secondary objective is to evaluate the safety after famitinib malate alone or combined administration with omeprazole in healthy adult subjects.
- Conditions
- Tumor
- Being tested
- famitinib、omeprazole
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
famitinib、omeprazoleDrug
famitinib malate, 25 mg on study day 1; omeprazole, 40 mg, qd on study day 10-14, 16-22; famotine malate together with omeprazole, on study day 15.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | The study will have only one study group in a fixed-sequence type of design. Receives: Drug: famitinib、omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: day 1 to day 23
AUC0-t
Measured: day 1 to day 23
AUC0-∞(if applicable)
Measured: day 1 to day 23
Tmax
Measured: day 1 to day 23
t1/2
Measured: day 1 to day 23
CL/F
Measured: day 1 to day 23
Vz/F
Measured: day 1 to day 23
Secondary outcomes (1)
The incidence and severity of adverse events/serious adverse events
Measured: from ICF signing date to approximate day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start7 Sep 2021
- Primary completion6 Oct 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label and fixed-sequence drug interaction study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041920
- Sponsor's protocol ID
- FMTN-I-111
- Status last verified
- May 2023
- First submitted
- 3 Sep 2021
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Single-arm, Open-label and Fixed-sequence Study to Evaluate the Effect of Omeprazole on Pharmacokinetics of Famitinib Malate in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05041920
- Acronym / sponsor ID
- FMTN-I-111
- Conditions
- Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 13 Sep 2021 (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.
The primary objective is to evaluate the effect of omeprazole on the pharmacokinetics of famitinib malate in healthy adult subjects.
The secondary objective is to evaluate the safety after famitinib malate alone or combined administration with omeprazole in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label and fixed-sequence drug interaction study.
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: famitinib、omeprazoleThe study will have only one study group in a fixed-sequence type of design. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants should sign the informed consent before the study, and fully understand the content, process and possible adverse reactions of the study;
- Capable to complete the study according to the requirements of study protocol;
- Healthy male and female subjects aged between 18 and 45 (inclusive) at the time of signing the informed consent, of which no less than 1/3 are female subjects;
- Participants should have no fertility plan from signing the informed consent until 6 months after the last medication, take effective contraceptive measures voluntarily and have no sperm donation plan. The serum HCG test of fertile women must be negative before Screening;
- Body weight ≥ 50.0 kg for men and body weight ≥ 45.0 kg for women, and body mass index (BMI) within the range of 19.0 to 28.0 kg /m2 (inclusive);
Key exclusion criteria (19 listed)
- Those who donated blood or suffered blood loss ≥400 mL within 3 months prior to Screening, donated blood or suffered blood loss ≥200 mL within 1 month prior to Screening, or received blood transfusion;
- Allergic constitution, including a history of severe drug/food allergy; Any history of allergy to famitinib malate capsules or omeprazole magnesium enteric-coated tablets;
- Any history of drug abuse, positive results for alcohol, nicotine or drugs at Screening;
- Those who have heavy smokers and alcoholic will not be able to prohibit smoking and alcohol during the trial;
- Any history of dysphagia or any gastrointestinal disease that affects drug absorption;
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 |
|---|---|---|
| famitinib、omeprazolefamitinib malate, 25 mg on study day 1; omeprazole, 40 mg, qd on study day 10-14, 16-22; famotine malate together with omeprazole, on study day 15. | Drug | Single arm |
Primary outcome
Cmax
Time frame: day 1 to day 23
AUC0-t
Time frame: day 1 to day 23
AUC0-∞(if applicable)
Time frame: day 1 to day 23
Tmax
Time frame: day 1 to day 23
t1/2
Time frame: day 1 to day 23
CL/F
Time frame: day 1 to day 23
Vz/F
Time frame: day 1 to day 23
1 secondary outcome
The incidence and severity of adverse events/serious adverse events
Time frame: from ICF signing date to approximate day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 famitinib、omeprazole in people with Tumor, run by Jiangsu HengRui Medicine 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 6 inclusion and 19 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: finished, as of the sponsor's last update on 24 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: day 1 to day 23). The study lists 7 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 24 May 2023.