A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers

Advanced Malignant Solid Tumors Clinical Trial

Official title:

A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of CM082 Tablet.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126668
• Other study ID #: CM082-CA-I-106
• Status: Completed
• Phase: Phase 1
• Start date: December 19, 2019
• Est. completion date: January 16, 2020

Study information

• Verified date: May 2020
• Source: AnewPharma
• 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 CM082 tablet.

Description:

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet in Chinese Healthy Volunteers. In addition, the safety of CM082 tablet 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: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• age: 18 - 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;

• Abstinence or physical contraception approved by researchers must be approved during and within three months after the trial is completed; and no sperm and egg donation plan is available;

• 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;

• The researchers determined that there were other conditions that were not suitable for the trial;

Related Conditions & MeSH terms

• Advanced Malignant Solid Tumors

Intervention

Drug:
• CM082 with fed or fasting
The two groups of subjects were given an equal dose of CM082 tablet (200 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 CM082.

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
AnewPharma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak plasma concentration (Cmax) of CM082	The effect of food on Cmax after high fat diet and fasting Blood sampling over a 72 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?10?12?24?36?48?72hour (after administration)
Primary	Area under the plasma concentration versus time curve (AUC) of CM082	The effect of food on AUC after high fat diet and fasting Blood sampling over a 72 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?10?12?24?36?48?72hour (after administration)
Primary	Time of maximum concentration(Tmax)of CM082	The effect of food on Tmax after high fat diet and fasting Blood sampling over a 72 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?10?12?24?36?48?72hour (after administration)
Primary	Half life(T1/2)of CM082	The effect of food on T1/2 after high fat diet and fasting Blood sampling over a 72 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?10?12?24?36?48?72hour (after administration)
Secondary	Percentage of adverse events	Percentage of adverse events as assessed by CTCAE v4.03	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