- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04434326
The Absorption, Metabolism and Excretion of [14C]CM082 in Human
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Jiangsu
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Nanjing, Jiangsu, China, 210029
- Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: [14C]CM082
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
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radioactivity concentration of each plasma sample
Time Frame: Day 1-Day6
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Use liquid scintillation counter to evaluate Radioactivity concentration of each plasma(DPM/ml) sample
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Day 1-Day6
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Radioactivity concentration of each urine samples
Time Frame: Day-1-Day11
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Use liquid scintillation counter to evaluate Radioactivity concentration of each urine(DPM/ml) sample
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Day-1-Day11
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Radioactivity concentration of each feces sample
Time Frame: Day-1-Day11
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Use liquid scintillation counter to evaluate Radioactivity concentration of each feces(DPM/g) sample
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Day-1-Day11
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Total recovery of radioactivity in urine and feces
Time Frame: Day-1-Day11
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Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample.
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Day-1-Day11
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Identification of metabolites in plasma, urine and fecal samples
Time Frame: Day-1-Day11
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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
|
Day-1-Day11
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma drug concentrations
Time Frame: Day-1-Day11
|
To determine the plasma concentrations of CMO82 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters
|
Day-1-Day11
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time Frame: Day-14-Day11
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According to CTCAE v4.03, the number and frequency of adverse events after a single dose of test drug were assessed.
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Day-14-Day11
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Feng Shao, Ph D, Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
- Principal Investigator: Wei Liu, M.A, Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CM082-CA-I-109
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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