Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
Nanjing, Jiangsu, 210029, China
NCT Number: NCT04434326
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
Looking for future studies?
Notify Me18 year–50 year
Male
Interventional
Phase 1
Nanjing, Jiangsu, 210029, China
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Day 1-Day6
Use liquid scintillation counter to evaluate Radioactivity concentration of each plasma(DPM/ml) sample
Time frame: Day-1-Day11
Use liquid scintillation counter to evaluate Radioactivity concentration of each urine(DPM/ml) sample
Time frame: Day-1-Day11
Use liquid scintillation counter to evaluate Radioactivity concentration of each feces(DPM/g) sample
Time frame: Day-1-Day11
Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample.
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
Time frame: Day-1-Day11
To determine the plasma concentrations of CMO82 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters
Time frame: Day-14-Day11
According to CTCAE v4.03, the number and frequency of adverse events after a single dose of test drug were assessed.
AnewPharma
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04374877
Adenocarcinoma, Advanced Solid Tumor
Duarte, California, United States
View Trial DetailsNCT06470763
Advanced Solid Tumor
Detroit, Michigan, United States
View Trial DetailsNCT06403436
Adult Disease, Adult Solid Tumor
Nashville, Tennessee, United States
View Trial DetailsNCT03239145
Adnexal Diseases, Advanced Solid Tumor
Boston, Massachusetts, United States
View Trial Details