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

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Ensartinib with fed or fasting

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Period 1: fed control → Period 2: fasted control; 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	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.
Experimental: Period 1: fasted control → Period 2: fed control; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Study Chair: zourong ruan, The Second Affiliated Hospital of Zhejiang University Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): August 2, 2018
• Study Completion (Actual): August 2, 2018

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Ensartinib
• Other Study ID Numbers: BTP-44313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No