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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04126668
Other study ID # CM082-CA-I-106
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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