Non-Small Cell Lung CancerPhase 1NCT03510611

A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers.

A Phase 1 study testing Ensartinib with fed or fasting in people with Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals 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 main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Ensartinib with fed or fasting
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 12 Mar 2018to 2 Aug 2018
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

age: 20 - 45 years;
sex: male and female;
body weight: Male ≥ 50 kg,female ≥ 45 kg, body mass index BMI (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border);
Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests;
written informed consent;

Who cannot join

Received any investigational drugs within 14 days before the screening test;
Donated 200 mL of whole blood within 30 days before the screening test,or Donated 200 mL of whole blood during the study or within 30 days after completion of the study;
Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period;
History of drug or food allergies;
Abnormal blood pressure or pulse，Abnormal laboratory tests;
Participated in other clinical trials within 3 months before screening;

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Smoking and drinking within 3 months before screening or test results of smoke, alcohol, and drug abuse are positive;Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody;Clinically apparent disease/infection within 1 month before screening;
Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody;
Clinically apparent disease/infection within 1 month before screening;

Trial locations and contacts

1 site in 1 country.

China1 site

The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, 311009

Other trials in China

About this study

Official title: A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.

Read the detailed description

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers. In addition, the safety of Ensartinib Capsules in Chinese Healthy Volunteers who with High-fat meal or fasting state will also be evaluated.

Conditions: Non-Small Cell Lung Cancer
Being tested: Ensartinib with fed or fasting
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

Ensartinib with fed or fastingDrug
The two groups of subjects were given an equal dose of Ensartinib capsules (225 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of Ensartinib.

Study groups in NCT03510611
Study group	Role	What they receive
Period 1: fed control → Period 2: fasted control	Experimental	Period 1: administration of Ensartinib 225mg at 7:30am, 30 minutes after the breakfast；Period 2: administration of Ensartinib 225mg at 7:30am, without the breakfast Receives: Drug: Ensartinib with fed or fasting
Period 1: fasted control → Period 2: fed control	Experimental	Period 1: administration of Ensartinib 225mg at 7:30am, without the breakfast；Period 2: administration of Ensartinib 225mg at 7:30am, 30 minutes after the breakfast Receives: Drug: Ensartinib with fed or fasting

What is being measured

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

Peak plasma concentration (Cmax) of Ensartinib
The effect of food on Cmax after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
Measured: pre-dose(30minute),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
The effect of food on AUC after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
Measured: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
Time of maximum concentration（Tmax）of Ensartinib
The effect of food on Tmax after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
Measured: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
Half life（T1/2）of Ensartinib
The effect of food on T1/2 after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
Measured: pre-dose(30minute),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 adverse events
Percentage of adverse events as assessed by CTCAE v4.0
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months

Timeline

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

12 Mar 20182 Aug 2018

First posted27 Apr 2018
Study start12 Mar 2018
Primary completion2 Aug 2018
Study completion2 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03510611
Sponsor's protocol ID: BTP-44313
Status last verified: Jul 2019
First submitted: 28 Mar 2018
Last updated: 24 Jul 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

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All Non-Small Cell Lung Cancer trials

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: A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.
ClinicalTrials.gov ID: NCT03510611
Acronym / sponsor ID: BTP-44313
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 12 Mar 2018 (actual)
Primary completion: 2 Aug 2018 (actual)
Study completion: 2 Aug 2018 (actual)
First posted: 27 Apr 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 Effect of Food on the Pharmacokinetics of Ensartinib Capsules.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Period 1: fed control → Period 2: fasted control	Experimental	Drug: Ensartinib with fed or fastingPeriod 1: administration of Ensartinib 225mg at 7:30am, 30 minutes after the breakfast；Period 2: administration of Ensartinib 225mg at 7:30am, without the breakfast
Period 1: fasted control → Period 2: fed control	Experimental	Drug: Ensartinib with fed or fastingPeriod 1: administration of Ensartinib 225mg at 7:30am, without the breakfast；Period 2: administration of Ensartinib 225mg at 7:30am, 30 minutes after the breakfast

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

age: 20 - 45 years;
sex: male and female;
body weight: Male ≥ 50 kg,female ≥ 45 kg, body mass index BMI (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border);
Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests;
written informed consent;

Key exclusion criteria (9 listed)

Received any investigational drugs within 14 days before the screening test;
Donated 200 mL of whole blood within 30 days before the screening test,or Donated 200 mL of whole blood during the study or within 30 days after completion of the study;
Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period;
History of drug or food allergies;
Abnormal blood pressure or pulse，Abnormal laboratory tests;

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 with fed or fastingThe two groups of subjects were given an equal dose of Ensartinib capsules (225 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of Ensartinib.	Drug	Period 1: fasted control → Period 2: fed control, Period 1: fed control → Period 2: fasted control

Primary outcome

Peak plasma concentration (Cmax) of Ensartinib
Time frame: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The effect of food on Cmax after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
Area under the plasma concentration versus time curve (AUC) of Ensartinib
Time frame: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The effect of food on AUC after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
Time of maximum concentration（Tmax）of Ensartinib
Time frame: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The effect of food on Tmax after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions
Half life（T1/2）of Ensartinib
Time frame: pre-dose(30minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour
The effect of food on T1/2 after high fat diet and fasting Blood sampling over a 120 hour period post dose in all dosing sessions

1 secondary outcome

Percentage of adverse events
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 months

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.
Individual participant dataSharing planned: No

Related trials for Non-Small Cell Lung Cancer

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
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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.

zourong ruan study chair

the Second Affiliated Hospital of Zhejiang University Medical College

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 with fed or fasting in people with Non-Small Cell 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 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 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 (time frame: pre-dose(30minute),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 4 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 NCT03510611.

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; AzTrials last refreshed its copy on 7 Nov 2026.