Healthy SubjectsPhase 1NCT05473468
Single Dose Study To Study The Absorption, Metabolism And Excretion Of Famitinib
A Phase 1 study testing Famitinib in people with Healthy Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of famitinib in healthy adult male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Famitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2022to Nov 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male between the ages of 18 and 45 years;
- Total body weight ≥ 50 kg, and the Body Mass Index (BMI) of 19 to 28 kg/m2;
- Male subjects of childbearing potential and their partners have no birth or sperm donation plan and voluntarily take effective contraception during the course of clinical trial until 6 months after the drug administration;
- An informed consent document signed and dated by the subject;
- Normal bowel movements (1 to 2 times a day), no habitual constipation or diarrhea.
Who cannot join
- No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests;
- Positive results of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or treponema pallidum antibody;
- Have taken any clinical trial drug or participated in any clinical trial within 3 months before administration;
- CYP3A4 inducers or inhibitors were taken within 28 days before administration;
- Have taken any prescription or over-the-counter drugs, vitamin products, health care drugs, traditional Chinese medicines or food supplements within 14 days before administration;
- Those who need to receive anticoagulant therapy such as warfarin or thrombin inhibitors and/or aspirin antiplatelet therapy within 1 month before administration and during the study period;
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- There are clinically significant bleeding symptoms or clear bleeding tendencies within 3 months before administration, such as gastrointestinal bleeding and peptic ulcers;
- History of stroke or intracranial hemorrhage within 6 months before administration;
- Have uncontrolled clinical symptoms or diseases of the heart, such as: (1) heart failure above NYHA2 (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) screening period QTcF >450 ms (male);
- Those who have undergone major surgery within 6 months before administration or that surgical incision has not completely healed; Major surgery includes, but is not limited to, any surgery that is at significant risk of bleeding, prolongs the period of general anesthesia, or has an incision biopsy or significant traumatic injury;
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before administration;
- Hemorrhoids or perianal diseases accompanied by regular / hematochezia; Those with gastrointestinal abnormalities such as irritable bowel syndrome and inflammatory bowel disease, which may affect drug absorption as determined by investigator;
- People with allergic constitution or allergic diseases, including those with severe drug allergies or history of drug allergies, and those who are known to be allergic to famitinib or excipients;
- Have any history of clinical serious diseases or diseases or conditions that the researcher believes may affect the results of the trial, including but not limited to circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, psychiatric and metabolic disease history; Lifestyle Habits;
- History of alcoholism with alcohol consumption over 14 units per week;; and can't abstain from smoking and alcohol during the study;
- Heavy smoker or habitually use nicotine-containing products;
- Have a history of drug abuse or have used soft drugs (such as: marijuana) within 3 months before administration or take drugs (such as cocaine, amphetamines, phencyclidine, etc.) within 1 year before administration; or positive urine drug abuse test during screening periods;
- Habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages (more than 8 cups a day, 1 cup = 250 mL) and unable to quit during the study period;
- Those who cannot tolerate venipuncture or with a history of needle-sickness and blood-sickness;
- Workers who require long-term exposure to radioactive conditions; or those who have significant radiation exposure (≥ 2 chest/abdominal CT scans, or 3 other X-ray tests ≥) within 1 year prior to administration or who have participated in radiopharmaceutical labeling tests;
- Blood donation no less than 400 mL or have blood transfusion within 3 months of dosing;
- Subjects who, in the opinion of the Investigator should not participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 200000
About this study
Official title: A Single Center, Single Dose, Open Label Phase 1 Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance And Metabolism Of [14c]-Famitinib In Healthy Adult Male Subjects
The purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of famitinib in healthy adult male subjects.
- Conditions
- Healthy Subjects
- Being tested
- Famitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamitinibDrug
a single oral dose of [14C]famitinib (25 mg/150 uCi suspension)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: Famitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance recovery of total radioactivity in all excreta urine: CumAe and Cum%Ae
Amount and cumulative amount excreted and expressed as the percentage of the administered dose into the urine from time t1 to time t2
Measured: 0-336 hours
Mass balance recovery of total radioactivity in all excreta feces: CumAe and Cum%Ae
Amount and cumulative amount excreted and expressed as the percentage of the administered dose into the feces from time t1 to time t2
Measured: 0-336 hours
Total recovery of radioactivity in urine and feces as percentage of total radioactive dose administered
To characterize the extent of excretion of total radioactivity in urine and feces following administration of famitinib
Measured: 0-336 hours
Metabolic Profiling in Blood
Metabolic profiling/identification and determination of relative abundance of famitinib and the metabolites of famitinib in plasma if possible.
Measured: 0 to 240 hours
Metabolic Profiling in Urine
Metabolic profiling/identification and determination of relative abundance of famitinib and the metabolites of famitinib in urine if possible.
Measured: 0-336 hours
Metabolic Profiling in Feces
Metabolic profiling/identification and determination of relative abundance of famitinib and the metabolites of famitinib in feces if possible.
Measured: 0-336 hours
Ratio of radioactivity of whole blood and plasma blood
Measured: 0-72 hours
Radioactivity AUC
Measured: 0-240 hours
Plasma famitinib and SHR116637: AUC
Measured: 0-240 hours
Plasma famitinib and SHR116637: Cmax
Measured: 0-240 hours
Plasma famitinib and SHR116637: Tmax
Measured: 0-240 hours
Radioactivity Tmax
Measured: 0-240 hours
Radioactivity Cmax
Measured: 0-240 hours
Plasma famitinib and SHR116637: t1/2
Measured: 0-240 hours
Radioactivity t1/2
Measured: 0-240 hours
Secondary outcomes (1)
AEs and SAEs
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start26 Aug 2022
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Single oral dose of \[14c\]-Famitinib
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT05473468
- Sponsor's protocol ID
- FMTN-I-107
- Status last verified
- Nov 2022
- First submitted
- 20 Jul 2022
- Last updated
- 2 Nov 2022
- 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Single Dose, Open Label Phase 1 Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance And Metabolism Of [14c]-Famitinib In Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT05473468
- Acronym / sponsor ID
- FMTN-I-107
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 26 Jul 2022 (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 purpose of this study is to evaluate the excretion balance, metabolic profile and the routes of excretion of famitinib in healthy adult male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single oral dose of [14c]-Famitinib
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Famitinib |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult male between the ages of 18 and 45 years;
- Total body weight ≥ 50 kg, and the Body Mass Index (BMI) of 19 to 28 kg/m2;
- Male subjects of childbearing potential and their partners have no birth or sperm donation plan and voluntarily take effective contraception during the course of clinical trial until 6 months after the drug administration;
- An informed consent document signed and dated by the subject;
- Normal bowel movements (1 to 2 times a day), no habitual constipation or diarrhea.
Key exclusion criteria (22 listed)
- No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests;
- Positive results of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or treponema pallidum antibody;
- Have taken any clinical trial drug or participated in any clinical trial within 3 months before administration;
- CYP3A4 inducers or inhibitors were taken within 28 days before administration;
- Have taken any prescription or over-the-counter drugs, vitamin products, health care drugs, traditional Chinese medicines or food supplements within 14 days before administration;
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 |
|---|---|---|
| Famitiniba single oral dose of [14C]famitinib (25 mg/150 uCi suspension) | Drug | Treatment group |
Primary outcome
Mass balance recovery of total radioactivity in all excreta urine: CumAe and Cum%Ae
Time frame: 0-336 hours
Amount and cumulative amount excreted and expressed as the percentage of the administered dose into the urine from time t1 to time t2
Mass balance recovery of total radioactivity in all excreta feces: CumAe and Cum%Ae
Time frame: 0-336 hours
Amount and cumulative amount excreted and expressed as the percentage of the administered dose into the feces from time t1 to time t2
Total recovery of radioactivity in urine and feces as percentage of total radioactive dose administered
Time frame: 0-336 hours
To characterize the extent of excretion of total radioactivity in urine and feces following administration of famitinib
Metabolic Profiling in Blood
Time frame: 0 to 240 hours
Metabolic profiling/identification and determination of relative abundance of famitinib and the metabolites of famitinib in plasma if possible.
Metabolic Profiling in Urine
Time frame: 0-336 hours
Metabolic profiling/identification and determination of relative abundance of famitinib and the metabolites of famitinib in urine if possible.
Metabolic Profiling in Feces
Time frame: 0-336 hours
Metabolic profiling/identification and determination of relative abundance of famitinib and the metabolites of famitinib in feces if possible.
Ratio of radioactivity of whole blood and plasma blood
Time frame: 0-72 hours
Radioactivity AUC
Time frame: 0-240 hours
Plasma famitinib and SHR116637: AUC
Time frame: 0-240 hours
Plasma famitinib and SHR116637: Cmax
Time frame: 0-240 hours
Plasma famitinib and SHR116637: Tmax
Time frame: 0-240 hours
Radioactivity Tmax
Time frame: 0-240 hours
Radioactivity Cmax
Time frame: 0-240 hours
Plasma famitinib and SHR116637: t1/2
Time frame: 0-240 hours
Radioactivity t1/2
Time frame: 0-240 hours
1 secondary outcome
AEs and SAEs
Time frame: 0-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- 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 in people with Healthy 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 5 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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?
Results are not available in the source record.
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?
Mass balance recovery of total radioactivity in all excreta urine: CumAe and Cum%Ae (time frame: 0-336 hours). The study lists 15 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 2 Nov 2022.