Healthy SubjectsPhase 1NCT04341090
A Food Effect Study of Apatinib Mesylate in Healthy Subjects
A Phase 1 study testing Apatinib Mesylate in people with Healthy 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 high-fat and low-fat meal on the pharmacokinetics of apatinib mesylate in Chinese adult healthy subjects. The secondary objective of the study was to assess the safety of apatinib mesylate 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
- Healthy Subjects
- What is being tested?
- Apatinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2020to 6 Jul 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
- 18-45 years of age, male or female, each gender should be more than 1/4 of the whole sample size.
- The weight of male subject ≥50kg, weight of female subject ≥45kg, 19≤BMI≤28kg/m2
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG;
- Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
- Able to comprehend and willing to sign an informed consent form (ICF)
Who cannot join
- History of drug allergy, or allergic to apatinib or ingredients;
- Drinking 14 units of alcohol per week within 6 months prior dosing(1 unit = 360 mL of beer, or 150mL of wine) ;
- Take any prescription or traditional Chinese medicines within four weeks prior dosing; take any over-the-counter medication, vitamin products within two weeks before dosing;
- Take any clinical trial drugs within 3 months prior dosing;
- Participate in blood donation within 3 months before screening and donate blood volume ≥400mL or blood loss ≥400mL, or receive blood transfusion; or donate blood volume≥200mL or blood loss ≥200mL within 1 month prior dosing.
- Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
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- Anyone who refuse to stop ingest foods or drinks containing caffeine, xanthine or alcohol from 48 hours before dosing to the end of the study;
- Anyone who refuse to stop ingesting grapefruit or grapefruit-containing products from 7 days before dosing to the end of the study;
- The investigator believes that the subjects are not eligible to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101100
About this study
Official title: A Randomized, Open-label, Single Dose, Three-period, Six-sequences, Crossover Study of High-fat and Low-fat Meal Effect on the Pharmacokinetics of Apatinib Mesylate in Chinese Healthy Adult Subjects
The primary objective of the study was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of apatinib mesylate in Chinese adult healthy subjects.
The secondary objective of the study was to assess the safety of apatinib mesylate administered in adult healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- Apatinib Mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib MesylateDrug
Single dose of apatinib mesylate after high-fat meal, low fat meal and fast
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after fasted, the second dose will be after low-fat meal, the third dose will be after high-fat meal Receives: Drug: Apatinib Mesylate |
| Arm 2 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after high-fat meal, the second dose will be after fasted, the third dose will be after low-fat meal Receives: Drug: Apatinib Mesylate |
| Arm 3 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after low-fat meal, the second dose will be after high-fat meal, the third dose will be after fasted Receives: Drug: Apatinib Mesylate |
| Arm 4 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after fasted, the second dose will be after high-fat meal, the third dose will be after low-fat meal Receives: Drug: Apatinib Mesylate |
| Arm 5 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after low-fat meal, the second dose will be after fasted, the third dose will be after high-fat meal Receives: Drug: Apatinib Mesylate |
| Arm 6 | Experimental | Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after high-fat meal, the second dose will be after low-fat meal, the third dose will be after fasted Receives: Drug: Apatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Observed Plasma Concentration for apatinib [ Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours ]
Measured: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
AUC0-t
Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for apatinib
Measured: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
AUC0-inf
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for apatinib
Measured: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start13 May 2020
- Primary completion6 Jul 2020
- Study completion6 Jul 2020
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT04341090
- Sponsor's protocol ID
- HR-APTN-I-009
- Status last verified
- Oct 2021
- First submitted
- 8 Apr 2020
- Last updated
- 22 Oct 2021
- 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 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Three-period, Six-sequences, Crossover Study of High-fat and Low-fat Meal Effect on the Pharmacokinetics of Apatinib Mesylate in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04341090
- Acronym / sponsor ID
- HR-APTN-I-009
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 May 2020 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 10 Apr 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 apatinib mesylate in Chinese adult healthy subjects.
The secondary objective of the study was to assess the safety of apatinib mesylate 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 |
|---|---|---|
| Arm 1 | Experimental | Drug: Apatinib MesylateDrug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after fasted, the second dose will be after low-fat meal, the third dose will be after high-fat meal |
| Arm 2 | Experimental | Drug: Apatinib MesylateDrug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after high-fat meal, the second dose will be after fasted, the third dose will be after low-fat meal |
| Arm 3 | Experimental | Drug: Apatinib MesylateDrug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after low-fat meal, the second dose will be after high-fat meal, the third dose will be after fasted |
| Arm 4 | Experimental | Drug: Apatinib MesylateDrug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after fasted, the second dose will be after high-fat meal, the third dose will be after low-fat meal |
| Arm 5 | Experimental | Drug: Apatinib MesylateDrug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after low-fat meal, the second dose will be after fasted, the third dose will be after high-fat meal |
| Arm 6 | Experimental | Drug: Apatinib MesylateDrug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after high-fat meal, the second dose will be after low-fat meal, the third dose will be after fasted |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-45 years of age, male or female, each gender should be more than 1/4 of the whole sample size.
- The weight of male subject ≥50kg, weight of female subject ≥45kg, 19≤BMI≤28kg/m2
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG;
- Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
- Able to comprehend and willing to sign an informed consent form (ICF)
Key exclusion criteria (9 listed)
- History of drug allergy, or allergic to apatinib or ingredients;
- Drinking 14 units of alcohol per week within 6 months prior dosing(1 unit = 360 mL of beer, or 150mL of wine) ;
- Take any prescription or traditional Chinese medicines within four weeks prior dosing; take any over-the-counter medication, vitamin products within two weeks before dosing;
- Take any clinical trial drugs within 3 months prior dosing;
- Participate in blood donation within 3 months before screening and donate blood volume ≥400mL or blood loss ≥400mL, or receive blood transfusion; or donate blood volume≥200mL or blood loss ≥200mL within 1 month prior dosing.
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 |
|---|---|---|
| Apatinib MesylateSingle dose of apatinib mesylate after high-fat meal, low fat meal and fast | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
Primary outcome
Cmax
Time frame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
Maximum Observed Plasma Concentration for apatinib [ Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours ]
AUC0-t
Time frame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for apatinib
AUC0-inf
Time frame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours
Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for apatinib
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 22 Oct 2021.
- 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 Apatinib Mesylate 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 9 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 22 Oct 2021. 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: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours). 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 22 Oct 2021.