None listed
Conditions
Interventions
Experimental group:Single oral administration 75 mg/100 µCi [14C]Flonoltinib Maleate
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Chinese healthy adult male, aged 18-45 years; 2. Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2; 3. Participants had no plans to donate sperm during or after the trial period, and participants and their partners had no plans to have children during or after the trial period and voluntarily adopted strict contraceptive measures; 4. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
Exclusion criteria
Exclusion criteria: 1.Individuals who have undergone comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, thyroid function, urine routine, stool routine+occult blood, lipase, amylase), chest X-ray (upright), digital rectal examination, abdominal ultrasound (liver, gallbladder, pancreas, spleen, and kidney), ophthalmic examination (slit lamp, intraocular pressure, and fundus photography), and 12 lead electrocardiogram abnormalities with clinical significance; 2.Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR ^ 0.33)) corrected QT interval (QTcF)>450 milliseconds; 3.Allergic constitution, such as those with a known history of allergies to two or more substances, or those with allergic diseases, or those who are intolerant or allergic to the active ingredients of the test drug or its formulation components; 4.Individuals with habitual constipation or diarrhea, a history of malabsorption syndrome, or a history of severe nausea, vomiting, diarrhea, or constipation within the week prior to the screening period; 5.Those who have difficulty swallowing or any condition that may affect drug absorption (such as gastrectomy, cholecystectomy, gastric bypass surgery, duodenectomy, colectomy); 6. Any clinically significant history of chronic diseases or conditions that researchers believe may affect the test results, including but not limited to digestive system, cardiovascular system, respiratory system, endocrine system, nervous system, urinary system, musculoskeletal system, hematological system, immune system, psychiatric and metabolic disease history, etc.; 7.Individuals with a history of cardiovascular and cerebrovascular diseases, including transient ischemic attack, organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsional ventricular tachycardia, ventricular tachycardia, QT prolongation syndrome, or with symptoms of QT prolongation syndrome and family history (demonstrated by genetic evidence or sudden death of close relatives due to cardiac reasons at a young age); 8.Having undergone major surgery or incomplete healing of surgical incision within the previous 6 months prior to screening; Major surgeries include but are not limited to any surgery involving significant bleeding risk, prolonged general anesthesia period, or open biopsy or significant traumatic injury; 9.Discovering individuals with cold or infection symptoms during screening; 10.HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test; 11.Individuals who have used any drugs that cause QT interval prolongation (such as moxifloxacin, amisulpride, amiodarone, etc.), CYP3A4 inhibitors/inducers, P-gp inhibitors/inducers, etc. in the 30 days prior to screening; 12.Screening for any prescription drugs, over-the-counter drugs, herbal medicines, or food supplements (vitamins, calcium supplements) taken within 14 days or 5 half lives (whichever is longer) prior to administration; 13.Individuals who have taken any clinical trial medication or participated in any other clinical trial within the past 3 months prior to screening; 14.Individuals who have experienced blood loss or donated blood (>400 mL) within the previous 3 months, or who have received blood transfusions or blood components within the past 1 month, or who plan to donate blood within 3 months after the end of this trial; 15.Screening for individuals who have
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiopharmacokinetics;Total radioactivity of plasma, urine, and fecal samples;Pharmacokinetic analysis, radioactive excretion analysis, metabolite profiling analysis, and identification analysis of major metabolites; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, laboratory tests, vital signs, 12-lead electrocardiogram, physical examination; | — |
Countries
China
Contacts
Public ContactLiyan Miao
The First Affiliated Hospital of Soochow University
Outcome results
None listed