Advanced Malignant Solid TumorsPhase 1NCT04126668
A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers
A Phase 1 study testing CM082 with fed or fasting in people with Advanced Malignant Solid Tumors, run by AnewPharma at 1 site in China.
Trial summary
The main objective of this study is to evaluate the Effect of Food on the Pharmacokinetics of CM082 tablet. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- CM082 with fed or fasting
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2019to 16 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 10Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, 311009
About this study
Official title: 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.
Read the 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
- Being tested
- CM082 with fed or fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM082 with fed or fastingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Period 1: fasted control → Period 2: fed control | Experimental | 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 Receives: Drug: CM082 with fed or fasting |
| Period 1: fed control → Period 2: fasted control | Experimental | 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 Receives: Drug: CM082 with fed or fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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 outcomes (1)
Percentage of adverse events
Percentage of adverse events as assessed by CTCAE v4.03
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start19 Dec 2019
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnewPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- zourong ruan, Study chair, the Second Affiliated Hospital of Zhejiang University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126668
- Sponsor's protocol ID
- CM082-CA-I-106
- Status last verified
- May 2020
- First submitted
- 11 Oct 2019
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of CM082 Tablet.
- ClinicalTrials.gov ID
- NCT04126668
- Acronym / sponsor ID
- CM082-CA-I-106
- Conditions
- Advanced Malignant Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AnewPharmaIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1: fasted control → Period 2: fed control | Experimental | Drug: CM082 with fed or fastingPeriod 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 |
| Period 1: fed control → Period 2: fasted control | Experimental | Drug: CM082 with fed or fastingPeriod 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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；
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM082 with fed or fastingThe 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. | Drug | Period 1: fasted control → Period 2: fed control, Period 1: fed control → Period 2: fasted control |
Primary outcome
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
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
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No
Related trials for Advanced Malignant Solid Tumors
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
Active, not recruitingPhase 2
Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With TSC1 or TSC2 Genetic Changes (MATCH - Subprotocol M)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zourong ruan study chair
the Second Affiliated Hospital of Zhejiang University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM082 with fed or fasting in people with Advanced Malignant Solid Tumors, run by AnewPharma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.