Solid TumorPhase 1NCT05336279

Bioequivalence Study of Famitinib Malate in Healthy Volunteers Under Fasting Condition

A Phase 1 study testing famitinib malate T(5 mg*4)、famitinib malate R(20 mg) in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 28 healthy subjects. Subjects will receive famitinib malate on Day1 and Day13. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Solid Tumor
What is being tested?: famitinib malate T(5 mg*4)、famitinib malate R(20 mg)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteChina
Study dates: 11 May 2022to 20 Jun 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy subjects over 18 years old (including the boundary value).
Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value).
Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 28 weeks from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women before the enrollment should be negative.
The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent.

Who cannot join

Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results.
Those who have undergone surgery within 3 months before the trial, or plan to perform surgery during the study period.
Those who participate in blood donation within 3 months before screening and donate blood volume ≥ 400 mL or lose blood ≥ 400 mL, participate in blood donation within 1 month before screening and donate blood volume ≥ 200 mL or lose blood ≥ 200 mL, or receive blood transfusion.
Have a history of allergies to drugs, food or other substances.
Those who have used soft drugs (such as marijuana) within 3 months before screening, or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before screening; or those with positive results in urine drug abuse screening; or those who have a history of drug abuse or drug dependence within 5 years before screening.
Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration.

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Those who have taken any medicine within 4 weeks before the first administration (including prescription medicines, non-prescription medicines, Chinese herbal medicines, vitamins, calcium tablets and other food supplements).
Those who smoke more than 5 cigarettes per day within 3 months before screening and could not stop using any tobacco products during the trial.
Regular drinkers within 6 months before screening, that is, drinking more than 14 g of alcohol per week (1 g alcohol ≈ 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine), and any alcohol-containing products cannot be stopped during the study, and those with positive results in alcohol breath test.
Vital signs, vital signs, physical examination, 12-lead electrocardiogram, chest X-ray, abdominal ultrasound and clinical laboratory tests with abnormalities and clinical significance.
HBsAg positive, HCVAb positive, HIV antibody positive, syphilis antibody positive.
48 hours before the first dose until the end of the study, those who refuse to stop any beverages or foods containing methylxanthines, such as coffee, tea, cola, chocolate, etc.; 7 days before the first dose until the end of the study, those who refuse to stop using any beverage or food containing grapefruit; has special dietary requirements and cannot comply with the unified diet.
Those who have been vaccinated against 2019-nCOV, other inactivated or attenuated vaccines within 28 days before the first administration, or who plan to be vaccinated against 2019-nCoV during research.
Those with a history of fainting of blood or needles and intolerance to venipuncture.
Lactating women.
The researchers considered that the subjects had any other factors that were not suitable for the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of USTC
Jinan, Jinan, 230001

Other trials in China

About this study

Official title: A Single-center, Single-dose, Randomized, Open-label, Two-cycle, Crossover Study of Bioequivalence of Famitinib Malate Capsules of Different Specifications Taken Orally in Healthy Subjects Under Fasting Condition

The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 28 healthy subjects.

Subjects will receive famitinib malate on Day1 and Day13.

Conditions: Solid Tumor
Being tested: famitinib malate T(5 mg*4)、famitinib malate R(20 mg)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

famitinib malate T(5 mg*4)、famitinib malate R(20 mg)Drug
TR Group: famitinib malate T on day 1, famitinib malate R on day 13.
famitinib malate T(5 mg*4)、famitinib malate R(20 mg)Drug
RT Group: famitinib malate R on day 1, famitinib malate T on day 13.

Study groups in NCT05336279
Study group	Role	What they receive
Treatment group TR	Experimental	T - R Receives: Drug: famitinib malate T(5 mg*4)、famitinib malate R(20 mg)
Treatment group RT	Experimental	R -T Receives: Drug: famitinib malate T(5 mg*4)、famitinib malate R(20 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum observed plasma concentration (Cmax) of Famitinib
Measured: from Day1 to Day9 after the first cycle （each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Area under the plasma concentration versus time curve (AUC0-t) of Famitinib
Measured: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Area under the plasma concentration versus time curve (AUC0-∞) of Famitinib
Measured: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）

Secondary outcomes (10)

Time to maximum observed plasma concentration (Tmax) of Famitinib
Measured: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Elimination half-life (T1/2) of Famitinib
Measured: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Apparent oral clearance (CL/F) of Famitinib
Measured: from Day1 to Day9（each cycle is 9 days） after the first cycle and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Maximum observed plasma concentration (Cmax) of SHR116637
Measured: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Area under the plasma concentration versus time curve (AUC0-t) of SHR116637
Measured: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Area under the plasma concentration versus time curve (AUC0-∞) of SHR116637
Measured: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Time to maximum observed plasma concentration (Tmax) of SHR116637
Measured: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Time to elimination half-life (T1/2) of SHR116637
Measured: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Apparent oral clearance (CL/F) of SHR116637
Measured: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Number of subjects with adverse events and the severity of adverse events
Measured: from Day1 to Day21 after the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 202220 Jun 2022

First posted20 Apr 2022
Study start11 May 2022
Primary completion27 May 2022
Study completion20 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid 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: Randomised
Intervention model: Crossover
Model description: The study is a single-center, single-dose, randomized, open-label, two-cycle, crossover study.
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05336279
Sponsor's protocol ID: FMTN-I-112
Status last verified: May 2023
First submitted: 19 Apr 2022
Last updated: 18 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Single-dose, Randomized, Open-label, Two-cycle, Crossover Study of Bioequivalence of Famitinib Malate Capsules of Different Specifications Taken Orally in Healthy Subjects Under Fasting Condition
ClinicalTrials.gov ID: NCT05336279
Acronym / sponsor ID: FMTN-I-112
Conditions: Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 11 May 2022 (actual)
Primary completion: 27 May 2022 (actual)
Study completion: 20 Jun 2022 (actual)
First posted: 20 Apr 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 study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 28 healthy subjects.

Subjects will receive famitinib malate on Day1 and Day13.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: The study is a single-center, single-dose, randomized, open-label, two-cycle, crossover study.

Arm	Type	Receives
Treatment group TR	Experimental	Drug: famitinib malate T(5 mg*4)、famitinib malate R(20 mg)T - R
Treatment group RT	Experimental	Drug: famitinib malate T(5 mg*4)、famitinib malate R(20 mg)R -T

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Healthy subjects over 18 years old (including the boundary value).
Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value).
Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 28 weeks from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women before the enrollment should be negative.
The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent.

Key exclusion criteria (16 listed)

Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results.
Those who have undergone surgery within 3 months before the trial, or plan to perform surgery during the study period.
Those who participate in blood donation within 3 months before screening and donate blood volume ≥ 400 mL or lose blood ≥ 400 mL, participate in blood donation within 1 month before screening and donate blood volume ≥ 200 mL or lose blood ≥ 200 mL, or receive blood transfusion.
Have a history of allergies to drugs, food or other substances.
Those who have used soft drugs (such as marijuana) within 3 months before screening, or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before screening; or those with positive results in urine drug abuse screening; or those who have a history of drug abuse or drug dependence within 5 years before screening.

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 malate T(5 mg*4)、famitinib malate R(20 mg)TR Group: famitinib malate T on day 1, famitinib malate R on day 13.	Drug	Treatment group TR
famitinib malate T(5 mg*4)、famitinib malate R(20 mg)RT Group: famitinib malate R on day 1, famitinib malate T on day 13.	Drug	Treatment group RT

Primary outcome

Maximum observed plasma concentration (Cmax) of Famitinib
Time frame: from Day1 to Day9 after the first cycle （each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Area under the plasma concentration versus time curve (AUC0-t) of Famitinib
Time frame: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Area under the plasma concentration versus time curve (AUC0-∞) of Famitinib
Time frame: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）

10 secondary outcomes

Time to maximum observed plasma concentration (Tmax) of Famitinib
Time frame: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Elimination half-life (T1/2) of Famitinib
Time frame: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Apparent oral clearance (CL/F) of Famitinib
Time frame: from Day1 to Day9（each cycle is 9 days） after the first cycle and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Maximum observed plasma concentration (Cmax) of SHR116637
Time frame: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Area under the plasma concentration versus time curve (AUC0-t) of SHR116637
Time frame: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Area under the plasma concentration versus time curve (AUC0-∞) of SHR116637
Time frame: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Time to maximum observed plasma concentration (Tmax) of SHR116637
Time frame: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Time to elimination half-life (T1/2) of SHR116637
Time frame: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Apparent oral clearance (CL/F) of SHR116637
Time frame: from Day1 to Day9 after the first cycle（each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）
Number of subjects with adverse events and the severity of adverse events
Time frame: from Day1 to Day21 after the first dose

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 18 May 2023.
Individual participant dataSharing planned: Undecided

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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 malate T(5 mg*4)、famitinib malate R(20 mg) in people with Solid 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 4 inclusion and 16 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 18 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?

Maximum observed plasma concentration (Cmax) of Famitinib (time frame: from Day1 to Day9 after the first cycle （each cycle is 9 days） and from Day13 to Day21 after the second cycle（each cycle is 9 days）). 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 NCT05336279.

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 18 May 2023.