Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04126668
Recruitment Status : Completed
First Posted : October 15, 2019
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
AnewPharma

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

Condition or disease Intervention/treatment Phase
Advanced Malignant Solid Tumors Drug: CM082 with fed or fasting Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of CM082 Tablet.
Actual Study Start Date : December 19, 2019
Actual Primary Completion Date : January 16, 2020
Actual Study Completion Date : January 16, 2020

Arm Intervention/treatment
Experimental: 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
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.

Experimental: 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
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.




Primary Outcome Measures :
  1. Peak plasma concentration (Cmax) of CM082 [ Time Frame: 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) ]
    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

  2. Area under the plasma concentration versus time curve (AUC) of CM082 [ Time Frame: 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) ]
    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

  3. Time of maximum concentration(Tmax)of CM082 [ Time Frame: 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) ]
    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

  4. Half life(T1/2)of CM082 [ Time Frame: 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) ]
    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


Secondary Outcome Measures :
  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 v4.03



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126668


Locations
Layout table for location information
China, Zhejiang
The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China, 311009
Sponsors and Collaborators
AnewPharma
Investigators
Layout table for investigator information
Study Chair: zourong ruan the Second Affiliated Hospital of Zhejiang University Medical College
Layout table for additonal information
Responsible Party: AnewPharma
ClinicalTrials.gov Identifier: NCT04126668    
Other Study ID Numbers: CM082-CA-I-106
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No