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

NCT03510611 | Completed Phase 1 DMC

• 1 other identifier: BTP-44313
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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

Study Arms (2)

Period 1: fed control → Period 2: fasted control

EXPERIMENTAL

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

Period 1: fasted control → Period 2: fed control

EXPERIMENTAL

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

Interventions

Ensartinib with fed or fasting DRUG

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.

Period 1: fasted control → Period 2: fed control; Period 1: fed control → Period 2: fasted control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, 311009, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ensartinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• zourong ruan

  the Second Affiliated Hospital of Zhejiang University Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 27, 2018
• Study Start: March 12, 2018
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)