Clinical Study on the Mass Balance of Clifutinib

NCT07211165 | Completed Phase 1

• 1 other identifier: HEC73543-AML-104
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Male

Keywords

Clifutinib

Outcome Measures

Primary Outcomes (6)

• AUC0-∞

  Investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of \[14C\] Clifutinib

  From Day 1 of dosing to the Day 85 after dosing

• Tmax

  Investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of \[14C\] Clifutinib

  From Day 1 of dosing to the Day 85 after dosing

• Cmax

  Investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of \[14C\] Clifutinib

  From Day 1 of dosing to the Day 85 after dosing

• Percentage of metabolites in plasma relative to total exposure AUC (% AUC)

  Investigate the distribution of total radioactivity in plasma of male healthy subjects after a single oral administration of \[14C\] Clifutinib.

  From Day 1 of dosing to the Day 85 after dosing

• The total radioactivity

  Quantitative analysis was conducted on the total radioactivity in the feces and urine of male health subjects after oral administration of \[14C\] Clifutinib, to obtain the data on human recovery rate and determine the main excretion pathway.

  From Day 1 of dosing to the Day 85 after dosing

• Identification of major metabolites in plasma, urine, and fecal samples

  Obtain the radioactive metabolite profiles in plasma, urine and feces of male healthy subjects after oral administration of \[14C\]Clifutinib, identify the main metabolites, and determine the metabolic and elimination pathways.

  From Day 1 of dosing to the Day 85 after dosing

Secondary Outcomes (4)

• AUC0-∞

  From Day 1 of dosing to the Day 85 after dosing

• Tmax

  From Day 1 of dosing to the Day 85 after dosing

• Cmax

  From Day 1 of dosing to the Day 85 after dosing

• Frequency, type and severity of adverse events/serious adverse events; changes in vital signs, 12-lead ECGs, laboratory tests, etc.

  From Day 1 of dosing to the Day 85 after dosing

Study Arms (1)

[14C]Clifutinib

EXPERIMENTAL

On Day 1, subjects will receive a single oral dose of 40 mg/100 µCi \[14C\]Clifutinib

Drug: [14C]Clifutinib

Interventions

[14C]Clifutinib DRUG

The subjects are required to take the test drug on an empty stomach for at least 10 hours and without drinking water for 1 hour. After taking the drug, they should fast for 4 hours and refrain from drinking water for 1 hour.

[14C]Clifutinib

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Those with a history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, atrioventricular block, and the investigator deems it clinically significant; those with QTcF \> 450ms during the screening period.
• Those with interstitial lung disease, severely impaired lung function, severe pulmonary fibrosis, radiation pneumonitis, drug-induced lung disease, and evidence of active pulmonary inflammation on chest CT during the screening period, and the investigator deems it clinically significant.
• Those who have undergone major surgery within 6 months before the screening period or whose surgical incisions have not fully healed; major surgeries include but are not limited to any surgeries with significant bleeding risk, prolonged general anesthesia, or incisional biopsy or obvious traumatic injury, or surgeries that affect drug absorption, distribution, metabolism, and excretion, or those planning to undergo surgery during the study period.
• Those with drug, environmental, food allergies or allergic constitution, or those the investigator deems may be allergic to the study drug or its excipients.
• Those with hemorrhoids or perianal diseases with regular/ongoing bleeding, irritable bowel syndrome, inflammatory bowel disease.
• Those with multiple factors affecting oral and drug absorption (such as inability to swallow, post-gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, and intestinal obstruction, etc.).
• Those with habitual constipation or diarrhea.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Affiliated hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 7, 2025
• Study Start: September 29, 2025
• Primary Completion: November 5, 2025
• Study Completion: November 12, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)