- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04126668
A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers
May 20, 2020 updated by: AnewPharma
A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of CM082 Tablet.
The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 311009
- The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
|
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
|
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)
|
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
|
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)
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: zourong ruan, The Second Affiliated Hospital of Zhejiang University Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2019
Primary Completion (Actual)
January 16, 2020
Study Completion (Actual)
January 16, 2020
Study Registration Dates
First Submitted
October 11, 2019
First Submitted That Met QC Criteria
October 11, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
May 21, 2020
Last Update Submitted That Met QC Criteria
May 20, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM082-CA-I-106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Malignant Solid Tumors
-
AnewPharmaCompleted
-
Stemirna TherapeuticsPeking University Cancer Hospital & InstituteNot yet recruitingAdvanced Malignant Solid Tumors
-
HutchmedRecruitingAdvanced Malignant Solid TumorsChina
-
Hutchison Medipharma LimitedRecruitingAdvanced Malignant Solid TumorsChina
-
AnewPharmaShanghai East HospitalActive, not recruitingAdvanced Malignant Solid TumorsChina
-
Millennium Pharmaceuticals, Inc.TerminatedAdvanced Malignant Solid TumorsUnited States
-
Wyeth is now a wholly owned subsidiary of PfizerWithdrawnAdvanced Malignant Solid Tumors
-
Fudan UniversityUnknownAdvanced Malignant Solid TumorsChina
-
Peking University Cancer Hospital & InstituteRecruitingAdvanced Malignant Solid TumorsChina
Clinical Trials on CM082 with fed or fasting
-
Intermountain Health Care, Inc.CompletedCardiovascular DiseaseUnited States
-
Betta Pharmaceuticals Co., Ltd.CompletedNon-Small Cell Lung CancerChina
-
Dong-A ST Co., Ltd.Completed
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)Recruiting
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)Recruiting
-
Daiichi Sankyo, Inc.CompletedHealthy VolunteersUnited States
-
National Institute of Cardiology, Laranjeiras,...WithdrawnObesity | Overweight | Physical ActivityBrazil
-
NVP HealthcareCompletedLow Back PainKorea, Republic of
-
Janssen Research & Development, LLCCompleted