This study is a single-site, single-dose, non-randomized, open-label study to assess the absorption, metabolism, and excretion profile of \[14C\]X842 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects in China to ensure at least 4 evaluable subjects.
The healthy male subjects will be screened no more than 14 days before the dose (D-14 through D-3) and admitted to the clinical research center 2 days before the dose (D-2). The subjects will receive a single oral administration of approximately 50 mg/100 µCi \[14C\]X842 suspension orally on an empty stomach on day 1. Urine and feces samples will be all collected from the subjects before and at specified intervals between 0 and 312 hours after taking the drug and blood samples will be collected at specified time points between 0 and 216 hours before and after taking the drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
50 mg/100 µCi \[14C\] X842 suspension
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Mass balance: the cumulative excretion rate
To collect the total radioactive substances in excreta (urine and feces) and to calculate the cumulative excretion rate
Time frame: 22 days
Tmax (time to maximum observed concentration)
Tmax parameters of the total radioactivity in plasma
Time frame: 22 days
Cmax(maximum concentration)
Cmax parameters of the total radioactivity in plasma
Time frame: 22 days
AUC(area under curve)
AUC parameters of the total radioactivity in plasma
Time frame: 22 days
t1/2 (terminal elimination half-life)
t1/2 parameters of the total radioactivity in plasma
Time frame: 22 days
MRT (mean residence time)
MRT parameters of the total radioactivity in plasma
Time frame: 22 days
Vd/F(apparent volume of distribution)
Vd/F parameters of the total radioactivity in plasma
Time frame: 22 days
whole blood/plasma ratio for the total radioactivity concentration at different time points
whole blood/plasma ratio for the total radioactivity concentration at different time points
Time frame: 22 days
Percentage of the drug and its metabolites in plasma, urine and feces to the administered dose
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Exposure in plasma; percentage of the drug and its metabolites in urine and feces to the administered dose; identification of major metabolites in plasma, urine and feces
Time frame: 22 days
The nature and severity of AEs based on NCI-CTC AE V5.0
The nature and severity of adverse events were adjudicated in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)
Time frame: 22 days
The nature and incidence and severity of SAEs based on NCI-CTC AE V5.0
The nature and severity of serious adverse events were adjudicated in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0)
Time frame: 22 days
12-Electrocardiograms (ECG)
the data collection of heart rate, PR interval, QRS interval, QT, QTc, on D-1 and 2 hours (±30 min) after administration
Time frame: 22 days
vital signs of pulse
pulse (beats per minute)
Time frame: 22 days
vital signs of body temperature
body temperature (℃)
Time frame: 22 days
vital signs of blood pressure
measurements included systolic (mmHg) and diastolic (mmHg).
Time frame: 22 days
vital signs of respiratory rate
respiratory rate (breaths per minute).
Time frame: 22 days
Hematology - Number of participants with clinically significant abnormalities
including White blood cell count, lymphocyte count, neutrophil count, red blood cell count, hemoglobin, platelet count
Time frame: 22 days
Blood Chemistry - Number of participants with clinically significant abnormalities
Blood Biochemistry including: Total Bilirubin (TBIL), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-Glutamyl Transferase (GGT), Alkaline Phosphatase (ALP), Total Protein (TP), Albumin (ALB), Urea, Creatinine (Cr), Uric Acid (UA), Glucose (GLU), Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Low-Density Lipoprotein Cholesterol (LDL-C), Triglycerides (TG), Potassium (K+), Sodium (Na+), Chloride (Cl-), Lactate Dehydrogenase (LDH), Creatine Kinase (CK), Amylase (AMY).
Time frame: 22 days
Coagulation - Number of participants with clinically significant abnormalities
including Prothrombin Time (PT), Thrombin Time (TT), Activated Partial ,, hromboplastin Time (APTT/aPTT),Fibrinogen (FIB/Fg), International Normalized Ratio (INR)
Time frame: 22 days
Urinalysis - Number of participants with clinically significant abnormalities
Urinalysis including Urinary protein, urine sugar, urine ketone bodies, red blood cells, white blood cells, pH value
Time frame: 22 days
Fecal Occult Blood Test (FOBT) - Number of participants with positive result
Fecal Occult Blood Test (FOBT) result
Time frame: 22 days