Health, SubjectivePhase 1NCT04616716
A Food Effect Study of FMTN on Healthy Chinese Adult Subjects
A Phase 1 study testing FMTN in people with Health, Subjective, 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 high-fat and low-fat meal on the pharmacokinetics of FMTN in Chinese adult healthy subjects. The secondary objective of the study was to assess the safety of FMTN administered in adult healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- FMTN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2020to 20 Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign informed consent prior to the test, and fully understand the content, process and possible adverse reactions of the test;
- Be able to complete the study according to the requirements of the test plan;
- Healthy male and female subjects aged 18 to 45 years old (including values at both ends) on the day of signing the informed consent, with a ratio of 1:1.
- Subjects have no family planning and take effective contraceptive measures voluntarily from 2 weeks before screening to 6 months after the last medication. Serum HCG test of fertile women must be negative before screening;
- The body weight of male subjects is not less than 50kg, and that of female subjects is not less than 45kg, and the body mass index (BMI) is within the range of 19-28 kg/m2 (including the critical value);
Who cannot join
- Abnormalities judged by clinicians as clinically significant, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, or a history of serious cardiac, liver, kidney, digestive tract, nervous system, respiratory system, mental and metabolic abnormalities;
- Those who participated in blood donation with blood donation volume ≥400mL within 3 months before taking the first study drug, or those who received blood transfusion;
- Allergic constitution, including a history of severe drug allergy or drug allergy, allergy to malate famitinib capsule or its excipients;
- A history of drug use, drug screening positive or a history of drug abuse in the past five years or drug use in the 3 months prior to the trial;
- A history of heavy drinking (14 units of alcohol per week: 1 unit = 285mL beer, 25mL spirits or 100mL wine);
- Those who smoked more than 5 cigarettes per day in the first 3 months of the study;
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- women > 470 msec or men >450 msec of QT interval (QTcF) corrected by Fridericia method in 12-lead electrocardiogram;
- Left ventricular ejection fraction (LVEF) <50% in cardiac color ultrasound;
- Screening those who have received any surgery in the previous 6 months;
- Screening for long-term use of hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicol) within the first 6 months;
- have taken any clinical trial drug within 3 months prior to the first use of the study drug;
- Any drug that alters liver enzyme activity within 4 weeks prior to the first administration of the study drug;
- Any prescription or non-prescription drug, any vitamin product, health care product or herb taken within 2 weeks prior to the first use of the study drug;
- HCV antibody positive, HIV antibody positive, HBsAg positive, syphilis antibody positive;
- Ingestion of grapefruit or products containing grapefruit, caffeine and xanthine foods or beverages within 48 hours prior to taking the study drug;Strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion;
- have taken any alcoholic product within 24 hours prior to taking the study drug, or have been screened for alcohol positivity;
- Subjects who, in the opinion of the investigator, have other factors that are not appropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized,Open,Single-center,Three-cycle,Six-sequence Crossover Study to Investigate the Effects of a High-fat and Low-fat Diet on the Pharmacokinetics of Healthy Chinese Adult Subjects After Oral Administration of FMTN Tablets
The primary objective of the study was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of FMTN in Chinese adult healthy subjects.
The secondary objective of the study was to assess the safety of FMTN administered in adult healthy subjects.
- Conditions
- Health, Subjective
- Being tested
- FMTN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTNDrug
Single dose of FMTN after high-fat meal,low-fat meal and fast
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug:FMTN fasted in P1,low-fat diet in P2,high-fat diet in P3
FMTN administration in fasted condition in period 1,FMTN administration after low-fat diet in period 2,FMTN administration after high-fat diet in period 3 Receives: Drug: FMTN |
| 2 | Experimental | Drug:FMTN high-fat diet in P1,fasted in P2,low-fat diet in P3
FMTN administration after high-fat diet in period 1,FMTN administration in fasted condition in period 2,FMTN administration after low-fat diet in period 3 Receives: Drug: FMTN |
| 3 | Experimental | Drug:FMTN low-fat diet in P1,high-fat diet P2,fasted in P3
FMTN administration after low-fat diet in period 1,FMTN administration after high-fat diet in period 2,FMTN administration in fasted condition in period 3 Receives: Drug: FMTN |
| 4 | Experimental | Drug:FMTN fasted in P1,high-fat diet P2,low-fat diet in P3
FMTN administration in fasted condition in period 1,FMTN administration after high-fat diet in period 2,FMTN administration after low-fat diet in period 3 Receives: Drug: FMTN |
| 5 | Experimental | Drug:FMTN low-fat diet in P1,fasted P2,high-fat diet in P3
FMTN administration after low-fat diet in period 1,FMTN administration in fasted condition in period 2,FMTN administration after high-fat diet in period 3 Receives: Drug: FMTN |
| 6 | Experimental | Drug:FMTN high-fat diet in P1,low-fat diet P2,fasted in P3
FMTN administration after high-fat diet in period 1,FMTN administration after low-fat diet in period 2,FMTN administration in fasted condition in period 3 Receives: Drug: FMTN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Observed Plasma Concentration for FMTN
Measured: Day 1:0-192 hours (h) ;Day10:0-192 h; Day 19:0-19h
AUC0-t
Area under the concentration-time curve form 0(pre-dose) to time of last concentration of FMTN
Measured: Day 1:0-192 hours (h);Day 10:0-192 h; Day 19:0-192 h
AUC0-inf
Area under the concentration-time curve form 0(pre-dose) to infinite time of FMTN
Measured: Day 1:0-192 hours (h);Day 10:0-192 h; Day 19:0-19 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start6 May 2020
- Primary completion29 Sep 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT04616716
- Sponsor's protocol ID
- FMTN-I-104
- Status last verified
- Oct 2020
- First submitted
- 2 Nov 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Open,Single-center,Three-cycle,Six-sequence Crossover Study to Investigate the Effects of a High-fat and Low-fat Diet on the Pharmacokinetics of Healthy Chinese Adult Subjects After Oral Administration of FMTN Tablets
- ClinicalTrials.gov ID
- NCT04616716
- Acronym / sponsor ID
- FMTN-I-104
- Conditions
- Health, Subjective
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2020 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 5 Nov 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 high-fat and low-fat meal on the pharmacokinetics of FMTN in Chinese adult healthy subjects.
The secondary objective of the study was to assess the safety of FMTN administered in adult healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FMTNDrug:FMTN fasted in P1,low-fat diet in P2,high-fat diet in P3 FMTN administration in fasted condition in period 1,FMTN administration after low-fat diet in period 2,FMTN administration after high-fat diet in period 3 |
| 2 | Experimental | Drug: FMTNDrug:FMTN high-fat diet in P1,fasted in P2,low-fat diet in P3 FMTN administration after high-fat diet in period 1,FMTN administration in fasted condition in period 2,FMTN administration after low-fat diet in period 3 |
| 3 | Experimental | Drug: FMTNDrug:FMTN low-fat diet in P1,high-fat diet P2,fasted in P3 FMTN administration after low-fat diet in period 1,FMTN administration after high-fat diet in period 2,FMTN administration in fasted condition in period 3 |
| 4 | Experimental | Drug: FMTNDrug:FMTN fasted in P1,high-fat diet P2,low-fat diet in P3 FMTN administration in fasted condition in period 1,FMTN administration after high-fat diet in period 2,FMTN administration after low-fat diet in period 3 |
| 5 | Experimental | Drug: FMTNDrug:FMTN low-fat diet in P1,fasted P2,high-fat diet in P3 FMTN administration after low-fat diet in period 1,FMTN administration in fasted condition in period 2,FMTN administration after high-fat diet in period 3 |
| 6 | Experimental | Drug: FMTNDrug:FMTN high-fat diet in P1,low-fat diet P2,fasted in P3 FMTN administration after high-fat diet in period 1,FMTN administration after low-fat diet in period 2,FMTN administration in fasted condition in period 3 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sign informed consent prior to the test, and fully understand the content, process and possible adverse reactions of the test;
- Be able to complete the study according to the requirements of the test plan;
- Healthy male and female subjects aged 18 to 45 years old (including values at both ends) on the day of signing the informed consent, with a ratio of 1:1.
- Subjects have no family planning and take effective contraceptive measures voluntarily from 2 weeks before screening to 6 months after the last medication. Serum HCG test of fertile women must be negative before screening;
- The body weight of male subjects is not less than 50kg, and that of female subjects is not less than 45kg, and the body mass index (BMI) is within the range of 19-28 kg/m2 (including the critical value);
Key exclusion criteria (17 listed)
- Abnormalities judged by clinicians as clinically significant, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, or a history of serious cardiac, liver, kidney, digestive tract, nervous system, respiratory system, mental and metabolic abnormalities;
- Those who participated in blood donation with blood donation volume ≥400mL within 3 months before taking the first study drug, or those who received blood transfusion;
- Allergic constitution, including a history of severe drug allergy or drug allergy, allergy to malate famitinib capsule or its excipients;
- A history of drug use, drug screening positive or a history of drug abuse in the past five years or drug use in the 3 months prior to the trial;
- A history of heavy drinking (14 units of alcohol per week: 1 unit = 285mL beer, 25mL spirits or 100mL wine);
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 |
|---|---|---|
| FMTNSingle dose of FMTN after high-fat meal,low-fat meal and fast | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
Cmax
Time frame: Day 1:0-192 hours (h) ;Day10:0-192 h; Day 19:0-19h
Maximum Observed Plasma Concentration for FMTN
AUC0-t
Time frame: Day 1:0-192 hours (h);Day 10:0-192 h; Day 19:0-192 h
Area under the concentration-time curve form 0(pre-dose) to time of last concentration of FMTN
AUC0-inf
Time frame: Day 1:0-192 hours (h);Day 10:0-192 h; Day 19:0-19 h
Area under the concentration-time curve form 0(pre-dose) to infinite time of FMTN
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 5 Nov 2020.
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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 FMTN in people with Health, Subjective, 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 17 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 5 Nov 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 (time frame: Day 1:0-192 hours (h) ;Day10:0-192 h; Day 19:0-19h). 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?
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 5 Nov 2020.