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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510611
• Other study ID #: BTP-44313
• Status: Completed
• Phase: Phase 1
• Start date: March 12, 2018
• Est. completion date: August 2, 2018

Study information

• Verified date: July 2019
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Ensartinib 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.

Locations

Country	Name	City	State
China	The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Primary	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	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
Primary	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	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
Primary	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	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	Percentage of adverse events	Percentage of adverse events as assessed by CTCAE v4.0	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