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Solid TumorPhase 1NCT05046808

Pharmacokinetics Study of Famitinib Malate Capsules in Healthy Subjects

A Phase 1 study testing Famitinib Malate Capsules 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

This is a single-center, randomized, open-label study to compare the pharmacokinetic profiles of Famitinib and its metabolite SHR116637 at different doses/specifications. 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 Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
23 Sep 2021to 22 Nov 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Gender: healthy male and female subjects.
  • Age: 18 years old and above (including 18 years old).
  • Weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, body mass index [BMI=weight (kg)/height2 (m2)] is 19.0 to 26.0kg/m2 (including boundary values).
  • Subjects with fertility and their partners have no fertility plan and voluntarily take medically approved high-efficiency contraception methods (see appendix 1 for details), and no plan to donate eggs or sperm within 28 weeks after signing the informed consent. Women with childbearing potential must have a negative serum pregnancy test within 24 hours before taking the study drug for the first time.
  • Subjects must give informed consent to this study before the experiment, and voluntarily sign a written informed consent form.
  • The subject can communicate well with the researcher and can complete the research in accordance with the research regulations.

Who cannot join

  • Those who are allergic to the active ingredients of the preparation and related compounds and any excipients or are allergic to two or more drugs (or food).
  • Those who cannot follow a unified diet (such as intolerance to standard meals, etc.).
  • Those who cannot tolerate venepuncture, and those who have a history of fainting needles and bleeding.
  • There is a history of cardiovascular (such as hypertension), liver, kidney (such as chronic kidney disease), endocrine, blood system, respiratory system, malignant tumour, mental abnormality, severe infection, etc. or the existing above diseases that the researcher judges to be clinically significant.
  • Chronic or active gastrointestinal diseases such as esophagitis, gastritis, gastric ulcer, enteritis, gastrointestinal bleeding, gastroesophageal reflux disease, gastrointestinal obstruction, oesophageal varices, or gastrointestinal surgery (part of the digestive tract resection, cholecystectomy), etc., and the investigator believes that there is still clinical significance.
  • During the screening period, there are serious gastrointestinal symptoms (such as nausea, vomiting, stomach pain, abdominal pain, diarrheal, abdominal discomfort, abdominal distension, etc.), and the investigator believes that it is currently clinically meaningful.
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  • Patients with upper respiratory tract infection during the screening period, and the investigator believes that it is currently clinically significant.
  • Those who have undergone major surgery within 6 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, distribution, metabolism, and excretion (except for appendicitis surgery).
  • During the screening period, physical examination, vital signs, 12-lead electrocardiogram, chest radiograph, abdominal ultrasound, blood routine, blood biochemistry, urine routine, blood coagulation and thyroid function (FT3, FT4, TSH) abnormalities, the investigator judged that the abnormalities have clinical significance.
  • Abnormal test results of hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human immunodeficiency virus antibody have clinical significance.
  • Those who drank excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups a day, 1 cup = 200 mL) within 3 months before screening; or consumed any food or beverages containing caffeine within 48 hours before the first administration of the study drug (Such as coffee, strong tea, chocolate, etc.).
  • Those who have consumed any beverages or foods that are rich in xanthine or grapefruit ingredients or other beverages or foods that affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours before the first administration of the study drug.
  • Any drug that interacts with this drug has been used within 4 weeks before screening (see appendix 3).
  • Those who have used long-acting estrogen or progestin injections or implants within 6 months before the test; those who have used short-acting contraceptives within 30 days before the test.
  • Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health care products in the 14 days before the first administration of the study drug.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

Other trials in China

About this study

Official title: A Single-center, Randomized, Open-label Pharmacokinetic Study of Famitinib Malate Capsules in Healthy Subjects

This is a single-center, randomized, open-label study to compare the pharmacokinetic profiles of Famitinib and its metabolite SHR116637 at different doses/specifications.

Conditions
Solid Tumor
Being tested
Famitinib Malate Capsules

What participants receive

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

  • Famitinib Malate CapsulesDrug

    Famitinib Malate Capsules 10mg single dose

  • Famitinib Malate CapsulesDrug

    Famitinib Malate Capsules 15mg single dose

  • Famitinib Malate CapsulesDrug

    Famitinib Malate Capsules 20mg single dose

  • Famitinib Malate CapsulesDrug

    Famitinib Malate Capsules 10mg*2 single dose

  • Famitinib Malate CapsulesDrug

    Famitinib Malate Capsules 25mg single dose

Study groups in NCT05046808
Study groupRoleWhat they receive
Famitinib Malate Capsules 10mgExperimentalNot described
Receives: Drug: Famitinib Malate Capsules
Famitinib Malate Capsules 15mgExperimentalNot described
Receives: Drug: Famitinib Malate Capsules
Famitinib Malate Capsules 20mgExperimentalNot described
Receives: Drug: Famitinib Malate Capsules
Famitinib Malate Capsules 10mg*2ExperimentalNot described
Receives: Drug: Famitinib Malate Capsules
Famitinib Malate Capsules 25mgExperimentalNot described
Receives: Drug: Famitinib Malate Capsules

What is being measured

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

  1. Maximum observed plasma concentration (Cmax) for Famitinib after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  2. Area under the plasma concentration versus time curve (AUC0-t) for Famitinib after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  3. Area under the plasma concentration versus time curve (AUC0-∞) for Famitinib after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  4. Time to maximum observed plasma concentration (Tmax) for Famitinib after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  5. Elimination half-life (T1/2) for Famitinib after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  6. Apparent oral clearance (CL/F) for Famitinib after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  7. Apparent Volume of Distribution (Vz/F) Famitinib after Single dose

    Measured: from Day1 to Day9 after the first dose

  8. Maximum observed plasma concentration (Cmax) for SHR116637 after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  9. Area under the plasma concentration versus time curve (AUC0-t) for SHR116637 after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  10. Area under the plasma concentration versus time curve (AUC0-∞) for SHR116637 after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  11. Time to maximum observed plasma concentration (Tmax) for SHR116637 after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  12. Time to elimination half-life (T1/2) for SHR116637 after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  13. Apparent oral clearance (CL/F) for SHR116637 after Single dose

    Measured: from Day 1 to Day 9 after the first dose

  14. Apparent Volume of Distribution (Vz/F) SHR116637 after Single dose

    Measured: from Day 1 to Day 9 after the first dose

Secondary outcomes (1)

  1. Number of subjects with adverse events and severity of adverse events

    Measured: from Day 1 to Day 16 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.

  1. First posted16 Sep 2021
  2. Study start23 Sep 2021
  3. Primary completion8 Oct 2021
  4. Study completion22 Nov 2021

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05046808
Sponsor's protocol ID
FMTN-I-110
Status last verified
Jun 2023
First submitted
8 Sep 2021
Last updated
8 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Famitinib Malate Capsules 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 6 inclusion and 15 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 8 Jun 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) for Famitinib after Single dose (time frame: from Day 1 to Day 9 after the first dose). The study lists 14 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 NCT05046808.

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 8 Jun 2023.

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