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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
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
Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
Nanjing, Jiangsu, China
Radioactivity concentration of each plasma sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each plasma(DPM/ml) sample
Time frame: Day 1-Day6
Radioactivity concentration of each urine samples
Use liquid scintillation counter to evaluate Radioactivity concentration of each urine(DPM/ml) sample
Time frame: Day-1-Day11
Radioactivity concentration of each feces sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each feces(DPM/g) sample
Time frame: 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.
Time frame: 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
Time frame: Day-1-Day11
Plasma drug concentrations
To determine the plasma concentrations of CMO82 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters
Time frame: 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.
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Time frame: Day-14-Day11