Lung CancerPhase 1NCT03536481
Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers
A Phase 1 study testing ensartinib capsules (test product) and ensartinib capsules (reference product) in people with Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- ensartinib capsules (test product) and ensartinib capsules (reference product)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2018to 9 Jan 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive)
- Generally in good health, with no history of chronic disease or sever disease
- No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations
- No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation
- Written informed consent
Who cannot join
- History of food or drug allergies
- Clinical significant disease or disorders
- Received surgery in 3 months before screening, or have plan for surgery during the study
- Participated in other clinical trials within 3 months before screening
- Venipuncture intolerance
- Drug abusing in 6 months
Show all 12Show fewer
- Donated ≥200 mL of blood within 30 days before screening
- Pregnant or under lactation period (female subjects)
- Received any prescription drug, over-the-counter drug, Chinese herbal drug or vitamins in 2 weeks
- Received any vaccine in 4 weeks
- Excessively smoking, alcohol or coffin-containing beverage drinking in 3 months
- Other circumstances that is deemed not appropriate for the study
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
About this study
Official title: Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of Ensartinib Capsules in Healthy Chinese Volunteers Under Fasted State and After Meal
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.
Read the detailed description
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of ensartinib capsules in Chinese healthy volunteers will also be evaluated.
- Conditions
- Lung Cancer
- Being tested
- ensartinib capsules (test product), ensartinib capsules (reference product)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ensartinib capsules (test product)Drug
Also called X-396 capsules
Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals
ensartinib capsules (reference product)Drug
Also called X-396 capsules
Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions
| Study group | Role | What they receive |
|---|---|---|
| T-R cohort under fasted state | Experimental | Subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state. Receives: Drug: ensartinib capsules (test product); Drug: ensartinib capsules (reference product) |
| R-T cohort under fasted state | Experimental | Subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state. Receives: Drug: ensartinib capsules (test product); Drug: ensartinib capsules (reference product) |
| T-R cohort after meal | Experimental | Subjects will be administered with one single dose of ensartinib capsules (test product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) after meal. Receives: Drug: ensartinib capsules (test product); Drug: ensartinib capsules (reference product) |
| R-T cohort after meal | Experimental | Subjects will be administered with one single dose of ensartinib capsules (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) after meal. Receives: Drug: ensartinib capsules (test product); Drug: ensartinib capsules (reference product) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration(Cmax) of ensartinib(test product) after meal
The Cmax of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose
Measured: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
Peak plasma concentration(Cmax) of ensartinib(test product) under fasted sate
The Cmax of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose
Measured: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
Peak plasma concentration(Cmax) of ensartinib(reference product) after meal
The Cmax of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose
Measured: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
Peak plasma concentration(Cmax) of ensartinib(reference product) under fasted sate
The Cmax of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose
Measured: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) after meal
The AUC of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose
Measured: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) under fasted sate
The AUC of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose
Measured: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) after meal
The AUC of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose
Measured: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) under fasted sate
The AUC of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose
Measured: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
Secondary outcomes (1)
Percentage of participants with adverse events as assessed by CTCAE v4.03
Measured: from screening to post-study visit, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start11 Jun 2018
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tongyu Zhu, Principal investigator, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536481
- Sponsor's protocol ID
- BTP-44315
- Status last verified
- Jul 2019
- First submitted
- 15 Apr 2018
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of Ensartinib Capsules in Healthy Chinese Volunteers Under Fasted State and After Meal
- ClinicalTrials.gov ID
- NCT03536481
- Acronym / sponsor ID
- BTP-44315
- Conditions
- Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 24 May 2018 (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 main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.
Detailed description
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of ensartinib capsules in Chinese healthy volunteers will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T-R cohort under fasted state | Experimental | Drug: ensartinib capsules (test product), Drug: ensartinib capsules (reference product)Subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state. |
| R-T cohort under fasted state | Experimental | Drug: ensartinib capsules (test product), Drug: ensartinib capsules (reference product)Subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state. |
| T-R cohort after meal | Experimental | Drug: ensartinib capsules (test product), Drug: ensartinib capsules (reference product)Subjects will be administered with one single dose of ensartinib capsules (test product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) after meal. |
| R-T cohort after meal | Experimental | Drug: ensartinib capsules (test product), Drug: ensartinib capsules (reference product)Subjects will be administered with one single dose of ensartinib capsules (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) after meal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive)
- Generally in good health, with no history of chronic disease or sever disease
- No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations
- No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation
- Written informed consent
Key exclusion criteria (12 listed)
- History of food or drug allergies
- Clinical significant disease or disorders
- Received surgery in 3 months before screening, or have plan for surgery during the study
- Participated in other clinical trials within 3 months before screening
- Venipuncture intolerance
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 |
|---|---|---|
| ensartinib capsules (test product)Also: X-396 capsulesTest product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals | Drug | R-T cohort after meal, R-T cohort under fasted state, T-R cohort after meal, T-R cohort under fasted state |
| ensartinib capsules (reference product)Also: X-396 capsulesReference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions | Drug | R-T cohort after meal, R-T cohort under fasted state, T-R cohort after meal, T-R cohort under fasted state |
Primary outcome
Peak plasma concentration(Cmax) of ensartinib(test product) after meal
Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The Cmax of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose
Peak plasma concentration(Cmax) of ensartinib(test product) under fasted sate
Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The Cmax of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose
Peak plasma concentration(Cmax) of ensartinib(reference product) after meal
Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The Cmax of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose
Peak plasma concentration(Cmax) of ensartinib(reference product) under fasted sate
Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The Cmax of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose
Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) after meal
Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The AUC of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose
Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) under fasted sate
Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The AUC of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose
Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) after meal
Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The AUC of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose
Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) under fasted sate
Time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The AUC of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose
1 secondary outcome
Percentage of participants with adverse events as assessed by CTCAE v4.03
Time frame: from screening to post-study visit, assessed up to 28 days
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 24 Jul 2019.
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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.
Tongyu Zhu principal investigator
Shanghai Public Health Clinical Center
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 ensartinib capsules (test product) and ensartinib capsules (reference product) in people with Lung Cancer, run by Betta Pharmaceuticals 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 12 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 24 Jul 2019. 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?
Peak plasma concentration(Cmax) of ensartinib(test product) after meal (time frame: pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour). The study lists 8 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 24 Jul 2019.