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

Phase 1

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Ensartinib with fed or fasting

• Registration Number: NCT03510611
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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.

Study Timeline

• Study Start: 2018-03-12
• Study First Submitted: 2018-03-28
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-27
• Primary Completion: 2018-08-02
• Study Completion: 2018-08-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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;

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 1: fed control → Period 2: fasted control	Ensartinib with fed or fasting	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
Period 1: fasted control → Period 2: fed control	Ensartinib with fed or fasting	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

Primary Outcome Measures

Name	Time	Method
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
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
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College; 🇨🇳 Hangzhou, Zhejiang, China