Healthy Adult SubjectsPhase 1NCT04494659
A Drug-drug Interaction Trial to Evaluate the Pharmacokinetics Effect of Rifampicin on Famitinib
A Phase 1 study testing Famitinib capsule and Rifampicin capsule in people with Healthy Adult Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective of the study was to assess the effect of repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib. The secondary objective of the study was to assess the safety of Famitinib given alone versus Famitinib co-administered with Rifampicin. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- Famitinib capsule and Rifampicin capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2020to 31 Aug 2020
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 18 to 50 years old at the date of signing the informed consent;
- Male body weight ≥ 50kg, body mass index (BMI) within the range of 19 ~ 28 kg/m2 (including 19 and 28) (BMI= weight (kg)/height 2 (m2));
- Subjects have no childbirth plans and agree to take effective contraceptive measures within 3 months of the last medication;
- The subject can communicate well with the researcher, understand and comply with the requirements of the study, understand and sign the informed consent.
Who cannot join
- History of or currently suffering from any serious clinical diseases such as diseases in circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases may interfere with the test results;
- Any surgery within 6 months before screening, or plan to perform surgery during the study period, or who have previously undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, gastric reduction surgery, etc.)
- Blood donation or massive blood loss (≥200 mL), or received blood transfusion, or used blood products within 3 months before screening;
- History of allergy to drugs, food or other substances;
- Frequent use of sedatives, sleeping pills or other addictive drugs; History of drug abuse within 1 year prior to screening; Positive for urine drug abuse screening test;
- Participated in any clinical trial and took the study drug within 3 months prior to the first administration;
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- Used any prescription drug or herbal tonic within 1 month before the first administration; Have used any over-the-counter (OTC) medicines, food supplements (including vitamins, calcium tablets, etc.) within 2 weeks prior to the first administration;
- Those who had smoked more than 5 cigarettes per day in the previous 3 months before screening and could not stop using any tobacco products during the study period; Nicotinic test positive;
- Frequent drinkers in the previous 6 months before screening, i.e., those who drink more than 14 units of alcohol per week (1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine) and cannot stop using any alcoholic products during the study period; alcohol test positive;
- Abnormal vital signs, physical examination, 12-lead ECG, abdominal B-ultrasound, chest radiograph, routine blood test, biochemical test, routine urine test and blood coagulation test with clinical significance;
- Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive;
- Subjects have taken and do not agree to stop using any drink or food containing methylxanthine, such as coffee, tea, cola, chocolate, etc. from 48 hours before the first administration until end of the study;, subjects have taken and do not agree to discontinue any beverage or food containing grapefruit from 7 days prior to initial administration until end of the study; Those who have special requirements on diet and cannot follow a uniform diet;
- Subjects who are considered to have other factors that are not appropriate to participate in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Famitinib in Healthy Male Subjects
The primary objective of the study was to assess the effect of repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.
The secondary objective of the study was to assess the safety of Famitinib given alone versus Famitinib co-administered with Rifampicin.
- Conditions
- Healthy Adult Subjects
- Being tested
- Famitinib capsule, Rifampicin capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Famitinib capsuleDrug
Also called SHR1020
single dose and co-administrated with Rifampicin capsule
Rifampicin capsuleDrug
Also called Rifampicin
repeated doses of Rifampicin capsule
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | single dose of Famitinib on Day 1, and co-administered with Rifampicin on Day 16 Receives: Drug: Famitinib capsule; Drug: Rifampicin capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Famitinib
Pharmacokinetics parameters of Famitinib
Measured: Day 1 to Day 24
AUC0-t of Famitinib
Pharmacokinetics parameters of Famitinib
Measured: Day 1 to Day 24
AUCinf of Famitinib
Pharmacokinetics parameters of Famitinib
Measured: Day 1 to Day 24
Secondary outcomes (5)
Tmax of Famitinib
Pharmacokinetics parameters of Famitinib
Measured: Day 1 to Day 24
T1/2 of Famitinib
Pharmacokinetics parameters of Famitinib
Measured: Day 1 to Day 24
CL/F of Famitinib
Pharmacokinetics parameters of Famitinib
Measured: Day 1 to Day 24
Vz/F of Famitinib
Pharmacokinetics parameters of Famitinib
Measured: Day 1 to Day 24
incidence of adverse events/serious adverse events
safety evaluation based on NCI-CTC AE 5.0
Measured: from ICF signing date to approximate Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start20 Jul 2020
- Primary completion13 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult SubjectsStudies 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
- Repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT04494659
- Sponsor's protocol ID
- FMTN-I-105
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li T, Li X, Jiang X, Wang C, Sun F, Liu Y, Lin P, Shi P, Fu Y, Gao X, Zhang Y, Cao Y. The effect of rifampin on the pharmacokinetics of famitinib in healthy subjects. Cancer Chemother Pharmacol. 2022 Nov;90(5):409-415. doi: 10.1007/s00280-022-04474-8. Epub 2022 Sep 15.
PubMed 36107220
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Famitinib in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04494659
- Acronym / sponsor ID
- FMTN-I-105
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 31 Jul 2020 (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 of the study was to assess the effect of repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.
The secondary objective of the study was to assess the safety of Famitinib given alone versus Famitinib co-administered with Rifampicin.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Famitinib.
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Famitinib capsule, Drug: Rifampicin capsulesingle dose of Famitinib on Day 1, and co-administered with Rifampicin on Day 16 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects aged 18 to 50 years old at the date of signing the informed consent;
- Male body weight ≥ 50kg, body mass index (BMI) within the range of 19 ~ 28 kg/m2 (including 19 and 28) (BMI= weight (kg)/height 2 (m2));
- Subjects have no childbirth plans and agree to take effective contraceptive measures within 3 months of the last medication;
- The subject can communicate well with the researcher, understand and comply with the requirements of the study, understand and sign the informed consent.
Key exclusion criteria (13 listed)
- History of or currently suffering from any serious clinical diseases such as diseases in circulatory system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases may interfere with the test results;
- Any surgery within 6 months before screening, or plan to perform surgery during the study period, or who have previously undergone any surgery that affects gastrointestinal absorption (including gastrectomy, bowel resection, gastric reduction surgery, etc.)
- Blood donation or massive blood loss (≥200 mL), or received blood transfusion, or used blood products within 3 months before screening;
- History of allergy to drugs, food or other substances;
- Frequent use of sedatives, sleeping pills or other addictive drugs; History of drug abuse within 1 year prior to screening; Positive for urine drug abuse screening test;
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 capsuleAlso: SHR1020single dose and co-administrated with Rifampicin capsule | Drug | Single arm |
| Rifampicin capsuleAlso: Rifampicinrepeated doses of Rifampicin capsule | Drug | Single arm |
Primary outcome
Cmax of Famitinib
Time frame: Day 1 to Day 24
Pharmacokinetics parameters of Famitinib
AUC0-t of Famitinib
Time frame: Day 1 to Day 24
Pharmacokinetics parameters of Famitinib
AUCinf of Famitinib
Time frame: Day 1 to Day 24
Pharmacokinetics parameters of Famitinib
5 secondary outcomes
Tmax of Famitinib
Time frame: Day 1 to Day 24
T1/2 of Famitinib
Time frame: Day 1 to Day 24
CL/F of Famitinib
Time frame: Day 1 to Day 24
Vz/F of Famitinib
Time frame: Day 1 to Day 24
incidence of adverse events/serious adverse events
Time frame: from ICF signing date to approximate Day 31
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 29 Sep 2020.
- Derived from this study: PubMed 36107220Li T, Li X, Jiang X, Wang C, Sun F, Liu Y, Lin P, Shi P, Fu Y, Gao X, Zhang Y, Cao Y. The effect of rifampin on the pharmacokinetics of famitinib in healthy subjects. Cancer Chemother Pharmacol. 2022 Nov;90(5):409-415. doi: 10.1007/s00280-022-04474-8. Epub 2022 Sep 15.
- Individual participant dataSharing planned: No
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Healthy Subjects
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 capsule and Rifampicin capsule in people with Healthy Adult Subjects, 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 4 inclusion and 13 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 29 Sep 2020. 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 of Famitinib (time frame: Day 1 to Day 24). 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?
On the ClinicalTrials.gov record for NCT04494659, which also lists 1 linked publication.
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 29 Sep 2020.