Clinical trial NCT03510611: A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers.
Official title: A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of Ensartinib Capsules.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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;
* 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;

Primary outcomes:
measure: Peak plasma concentration (Cmax) of Ensartinib
timeFrame: 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
measure: Area under the plasma concentration versus time curve (AUC) of Ensartinib
timeFrame: 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
measure: Time of maximum concentration（Tmax）of Ensartinib
timeFrame: 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
measure: Half life（T1/2）of Ensartinib
timeFrame: 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:
measure: Percentage of adverse events
timeFrame: 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
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
Study officials:
affiliation: the Second Affiliated Hospital of Zhejiang University Medical College
name: zourong ruan
role: STUDY_CHAIR
References: