Skip to main content
OpenTrials
Completed

NCT Number: NCT03510611

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Hangzhou, Zhejiang, 311009, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

  1. Peak plasma concentration (Cmax) of Ensartinib

    Time frame: 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

  2. Area under the plasma concentration versus time curve (AUC) of Ensartinib

    Time frame: 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

  3. Time of maximum concentration(Tmax)of Ensartinib

    Time frame: 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

  4. Half life(T1/2)of Ensartinib

    Time frame: 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 outcomes

  1. Percentage of adverse events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Betta Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 27, 2018
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.