Non-Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGEnsartinib with fed or fasting
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.
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak plasma concentration (Cmax) of Ensartinib | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of adverse events | 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 | Percentage of adverse events as assessed by CTCAE v4.0 |
Countries
China
Outcome results
None listed