Clinical Study on the Mass Balance of Clifutinib (NCT07211165) | Clinical Trial Compass
CompletedPhase 1
Clinical Study on the Mass Balance of Clifutinib
China6 participantsStarted 2025-09-29
Plain-language summary
To investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of \[14C\]Clifutinib, the distribution of total radioactivity in whole blood and plasma, and to determine the main excretion and metabolic pathways.
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion criteria
✓. Healthy male, age: 18 - 45 years (inclusive of boundary values).
✓. Weight of no less than 50 kg, and body mass index (BMI) within the range of 19 kg/m2 - 26 kg/m2 (including critical values).
✓. Signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions.
✓. The subjects can communicate well with the researchers and complete the trial in accordance with the protocol.
Exclusion criteria
✕. Those with abnormal and clinically significant findings in comprehensive physical examination, routine laboratory tests (blood routine, blood biochemistry, C-reactive protein, coagulation function, urine routine), stool routine + occult blood, thyroid function, 12-lead electrocardiogram, chest CT, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, kidney), etc.
✕. Those who fail the vital sign examination and still fail after re-examination.
✕. Those with abnormal and clinically significant findings in ophthalmological examination (slit lamp, intraocular pressure, fundus photography).
✕. Those with abnormal and clinically significant findings in hepatitis B surface antigen, hepatitis B e antigen, anti-HCV IgG, HIV-Ag/Ab, and syphilis antibody tests, as determined by the investigator.
✕. Those who have used CYP3A4 inhibitors or inducers within 30 days before the screening period, as detailed in Appendix 1.
✕
What they're measuring
1
AUC0-∞
Timeframe: From Day 1 of dosing to the Day 85 after dosing
2
Tmax
Timeframe: From Day 1 of dosing to the Day 85 after dosing
3
Cmax
Timeframe: From Day 1 of dosing to the Day 85 after dosing
4
Percentage of metabolites in plasma relative to total exposure AUC (% AUC)
Timeframe: From Day 1 of dosing to the Day 85 after dosing
5
The total radioactivity
Timeframe: From Day 1 of dosing to the Day 85 after dosing
6
Identification of major metabolites in plasma, urine, and fecal samples
Timeframe: From Day 1 of dosing to the Day 85 after dosing
. Those who have used any prescription drugs, over-the-counter drugs, herbal health products, or food supplements (such as vitamins, calcium supplements) within 14 days before the screening period.
✕. Those with a history of or current diseases in the musculoskeletal system, nervous and mental system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, reproductive system, etc., and the investigator deems it clinically significant.
✕. Those with any diseases that increase the risk of elevated blood sugar, such as a history of primary diabetes, steroid-induced diabetes, other secondary diabetes, acute or chronic pancreatitis, and the investigator deems it clinically significant.