Advanced Solid TumorPhase 1NCT04434326
The Absorption, Metabolism and Excretion of [14C]CM082 in Human
A Phase 1 study testing [14]CM082 suspension in people with Advanced Solid Tumor, run by AnewPharma at 1 site in China.
Trial summary
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] CM082 in healthy Chinese male subjects. The study will be conducted into two steps:Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the completion date of… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- [14]CM082 suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2021to 22 Oct 2021
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.healthy male volunteers between the ages of 18 to 50 years old; 2.Body weight >=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2; 3.Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant; 4.Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 1 year after discontinuing treatment with the investigational product. Highly effective methods of birth control include using condom, contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptive pill, hypodermic implants or others; 5. Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.
Who cannot join
- 1.History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder; 2.Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody; 3.History of syncope / needle syncope and intolerable intravenous indwelling needle; 4.History of clinically significant disease or infection within 1 month before entering the study; 5.Abnormality in blood pressure, including hypertensive BP (SBP>=140 mmHg, or DBP >=90 mmHg), or hypotensive BP(SBP<90 mmHg, or DBP <=55 mmHg), Pulse rate<55 bpm or >100 bpm; 6.Long-QT syndrome or family history of it, or QTcB interval > 450 ms; intraventricular blocks or left/right bundle branch block or QRS>120ms; frequent ventricular ectopic beats (any 10s ECG ventricular premature beat >= 1 in screening period); or abnormal resting heart rate (> 100 bpm); 7.The following abnormal clinical laboratory values
- HGB < LLN, and is judged as clinically significant by the investigator;
- Abnormal ALP, ALB,TP,Cr,ALT,AST,BIL,Urea, GLU value, and is judged as clinically significant by the investigator; 8.Received any drug within 14 days before taking the investigational drug, including any prescription drug, OTC drug, herbal drug or health care products, except for vitamins and paracetamol; 9.History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs; 10.Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; 11.Hemorrhoids or perianal disease with regular/perianal bleeding; 12.Allergies, have allergies to two or more drugs or foods; or have known allergies to the components of the drug (Mannitol, sodium bicarbonate, sodium dodecyl citrate, sodium carboxymethylcellulose, povidone, silica, magnesium stearate); 13.Have donated 500ml or more of blood or plasma 2 months prior to the study drug administration, or more than 50ml within 2 weeks prior to administration; 14.Vaccination was administered within 6 months prior to screening or during screening; 15.History of drug or alcohol abuse; 16.Smoking (> 10 cigarette / day), drinking (> 15 g, pure alcohol / day, equivalent to 450 ml beer, 150 ml wine or 50 ml low-alcohol liquor), or abusing drugs(MOP, METmAMP, MTD, THC, AMP positive) within last 3 months; 17.Subject with mentally ill and could not understand the property, scope and possible consequences of the study; 18.subject in prison or whose freedom is restricted by administrative or legal issues; 19.Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study; 20.Investigator, pharmacist, CRC or research associate; 21.Participated in other clinical trials within 3 months before screening; 22.The subjects participated in the clinical trial of radioactive labeling within one year before taking the medicine; 23.Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations); 24.Investigators think that subjects are not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
Nanjing, Jiangsu, 210029
About this study
Official title: A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]CM082 After a Single Oral 200mg/100µCi Dose in Healthy Chinese Male Subjects
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] CM082 in healthy Chinese male subjects. The study will be conducted into two steps:Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the completion date of plasma, urine and feces sampling on the 3rd day post-dose and onwards. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 4-6 subjects will be adjusted according to the pilot study
Read the detailed description
Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning of Day 1 before dosing, subjects will be transferred to nuclear medical ward. And after an overnight fast of at least 10 h, subjects will receive a single oral dose of 200 mg (100 μCi) of [14C]CM082 as an oral suspension. Then, after two days of the dosing, subjects will be transferred back to Phase I Clinical Unit ward and confined to this unit until blood or excreta sampling and safety monitoring at the designated time points or intervals are complete
- Conditions
- Advanced Solid Tumor
- Being tested
- [14]CM082 suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14]CM082 suspensionDrug
Before administration, the solid powder for administration was placed at room temperature. 40 ml drinking water was added into the drug container to prepare the suspension for the subjects to take. After that, 200 ml drinking water was used to repeatedly rinse the drug container for many times, and the subjects continued to take the lotion. Take care not to spill the liquid out of the bottle when shaking
| Study group | Role | What they receive |
|---|---|---|
| [14C]CM082 | Experimental | To investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose (200mg, 100µCi) of [14C]CM082 to healthy Chinese male subjects Receives: Drug: [14]CM082 suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactivity concentration of each plasma sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each plasma(DPM/ml) sample
Measured: Day 1-Day6
Radioactivity concentration of each urine samples
Use liquid scintillation counter to evaluate Radioactivity concentration of each urine(DPM/ml) sample
Measured: Day-1-Day11
Radioactivity concentration of each feces sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each feces(DPM/g) sample
Measured: Day-1-Day11
Total recovery of radioactivity in urine and feces
Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample.
Measured: Day-1-Day11
Identification of metabolites in plasma, urine and fecal samples
LC-MS was used to identify the main metabolites in plasma, urine and feces, and finally to provide the main biotransformation pathway of CM082 in human body
Measured: Day-1-Day11
Secondary outcomes (2)
Plasma drug concentrations
To determine the plasma concentrations of CMO82 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters
Measured: Day-1-Day11
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
According to CTCAE v4.03, the number and frequency of adverse events after a single dose of test drug were assessed.
Measured: Day-14-Day11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start5 Jul 2021
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnewPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng Shao, Ph D, Principal investigator, Jiangsu Province Hospital Affiliated to Nanjing Madical University of MedicineWei Liu, M.A, Principal investigator, Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434326
- Sponsor's protocol ID
- CM082-CA-I-109
- Status last verified
- Nov 2021
- First submitted
- 12 Jun 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C]CM082 After a Single Oral 200mg/100µCi Dose in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT04434326
- Acronym / sponsor ID
- CM082-CA-I-109
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- AnewPharmaIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 16 Jun 2020 (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.
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] CM082 in healthy Chinese male subjects. The study will be conducted into two steps:Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the completion date of plasma, urine and feces sampling on the 3rd day post-dose and onwards. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 4-6 subjects will be adjusted according to the pilot study
Detailed description
Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning of Day 1 before dosing, subjects will be transferred to nuclear medical ward. And after an overnight fast of at least 10 h, subjects will receive a single oral dose of 200 mg (100 μCi) of [14C]CM082 as an oral suspension. Then, after two days of the dosing, subjects will be transferred back to Phase I Clinical Unit ward and confined to this unit until blood or excreta sampling and safety monitoring at the designated time points or intervals are complete
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]CM082 | Experimental | Drug: [14]CM082 suspensionTo investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose (200mg, 100µCi) of [14C]CM082 to healthy Chinese male subjects |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.healthy male volunteers between the ages of 18 to 50 years old; 2.Body weight >=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2; 3.Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant; 4.Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 1 year after discontinuing treatment with the investigational product. Highly effective methods of birth control include using condom, contraceptive sponge, contraceptive gel, contraceptive film, intrauterine device, oral or injectable contraceptive pill, hypodermic implants or others; 5. Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.
Key exclusion criteria (3 listed)
- 1.History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder; 2.Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody; 3.History of syncope / needle syncope and intolerable intravenous indwelling needle; 4.History of clinically significant disease or infection within 1 month before entering the study; 5.Abnormality in blood pressure, including hypertensive BP (SBP>=140 mmHg, or DBP >=90 mmHg), or hypotensive BP(SBP<90 mmHg, or DBP <=55 mmHg), Pulse rate<55 bpm or >100 bpm; 6.Long-QT syndrome or family history of it, or QTcB interval > 450 ms; intraventricular blocks or left/right bundle branch block or QRS>120ms; frequent ventricular ectopic beats (any 10s ECG ventricular premature beat >= 1 in screening period); or abnormal resting heart rate (> 100 bpm); 7.The following abnormal clinical laboratory values
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 |
|---|---|---|
| [14]CM082 suspensionBefore administration, the solid powder for administration was placed at room temperature. 40 ml drinking water was added into the drug container to prepare the suspension for the subjects to take. After that, 200 ml drinking water was used to repeatedly rinse the drug container for many times, and the subjects continued to take the lotion. Take care not to spill the liquid out of the bottle when shaking | Drug | [14C]CM082 |
Primary outcome
Radioactivity concentration of each plasma sample
Time frame: Day 1-Day6
Use liquid scintillation counter to evaluate Radioactivity concentration of each plasma(DPM/ml) sample
Radioactivity concentration of each urine samples
Time frame: Day-1-Day11
Use liquid scintillation counter to evaluate Radioactivity concentration of each urine(DPM/ml) sample
Radioactivity concentration of each feces sample
Time frame: Day-1-Day11
Use liquid scintillation counter to evaluate Radioactivity concentration of each feces(DPM/g) sample
Total recovery of radioactivity in urine and feces
Time frame: Day-1-Day11
Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample.
Identification of metabolites in plasma, urine and fecal samples
Time frame: Day-1-Day11
LC-MS was used to identify the main metabolites in plasma, urine and feces, and finally to provide the main biotransformation pathway of CM082 in human body
2 secondary outcomes
Plasma drug concentrations
Time frame: Day-1-Day11
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: Day-14-Day11
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 14 Nov 2022.
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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.
Feng Shao, Ph D principal investigator
Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
Wei Liu, M.A principal investigator
Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
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 [14]CM082 suspension in people with Advanced Solid Tumor, 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 1 inclusion and 3 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 14 Nov 2022. 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?
Radioactivity concentration of each plasma sample (time frame: Day 1-Day6). The study lists 5 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 14 Nov 2022.