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

NCT ID: NCT04126668

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2020-01-16

Brief Summary

The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet.

Detailed 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.

Conditions

Advanced Malignant Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Period 1: fasted control → Period 2: fed control

Period 1: administration of CM082 200 mg at 7:30am, without the breakfast；Period 2: administration of CM082 200 mg at 7:30am, 30 minutes after the breakfast

Group Type: EXPERIMENTAL

CM082 with fed or fasting

Intervention Type: DRUG

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.

Period 1: fed control → Period 2: fasted control

Period 1: administration of CM082 200 mg at 7:30am, 30 minutes after the breakfast；Period 2: administration of CM082 200 mg at 7:30am, without the breakfast

Group Type: EXPERIMENTAL

CM082 with fed or fasting

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AnewPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zourong ruan

Role: STUDY_CHAIR

the Second Affiliated Hospital of Zhejiang University Medical College

Locations

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

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

CM082-CA-I-106

Identifier Type: -

Identifier Source: org_study_id