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Healthy men help track Drug's journey through the body

NCT ID NCT07211165

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how healthy men absorb, break down, and eliminate a drug called clifutinib. Six men took a single dose with a radioactive tracer so researchers could follow the drug in blood, urine, and stool. The goal was to understand the drug's path and how the body gets rid of it, not to treat any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

Sep 2025

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy male, age: 18 - 45 years (inclusive of boundary values). 2. 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). 3. Signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions. 4. The subjects can communicate well with the researchers and complete the trial in accordance with the protocol. Exclusion Criteria: 1. 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. 2. Those who fail the vital sign examination and still fail after re-examination. 3. Those with abnormal and clinically significant findings in ophthalmological examination (slit lamp, intraocular pressure, fundus photography). 4. 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. 5. Those who have used CYP3A4 inhibitors or inducers within 30 days before the screening period, as detailed in Appendix 1. 6. 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. 7. 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. 8. 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. 9. 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. 10. 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. 11. 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. 12. Those with drug, environmental, food allergies or allergic constitution, or those the investigator deems may be allergic to the study drug or its excipients. 13. Those with hemorrhoids or perianal diseases with regular/ongoing bleeding, irritable bowel syndrome, inflammatory bowel disease. 14. 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.). 15. Those with habitual constipation or diarrhea. 16. Those with lactose intolerance (those who have experienced diarrhea after drinking milk). 17. Those who are heavy drinkers or have frequently consumed alcohol within 6 months before the screening period (more than 14 units of alcohol per week, 1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine), or those who cannot abstain from alcohol during the trial, or those with a breath alcohol test result \> 0 mg/100 mL during the screening period. 18. Those who smoke more than 5 cigarettes per day or habitually use nicotine-containing products within 3 months before the screening period and cannot quit during the trial. 19. Those who have abused drugs or used soft drugs (such as marijuana) within 3 months before the screening period or hard drugs (such as cocaine, amphetamines, phencyclidine, etc.) within 1 year before the screening period, or those with positive urine drug tests during the screening period. 20. Habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeine-containing beverages, and those who are unable to abstain during the trial period. 21. Workers exposed to radiation for long periods of time, or those who have had significant radiation exposure (≥2 chest/abdominal CTs or ≥3 other types of X-ray examinations) within one year prior to signing the ICF, or those who have participated in radiolabeled drug trials within one year prior to signing the ICF. 22. Those with a history of fainting at the sight of needles or blood, or those who have difficulty with blood collection or cannot tolerate venipuncture. 23. Those who have participated in other clinical trials and used other investigational drugs or devices within three months before screening or during the screening period, or those who plan to participate in other clinical trials during this study, or those who are not the subjects themselves. 24. Those who have received vaccinations within one month before screening or plan to receive vaccinations during the trial period. 25. Those who have plans to conceive or donate sperm within one year from signing the ICF to one year after receiving the investigational drug, or those who do not agree that both the subject and their spouse should take strict contraceptive measures during this period (see Appendix 3 for details). 26. Those who have lost or donated blood of 400 mL or more within three months before the screening period, or those who have received blood transfusions within one month. 27. Those who are considered unsuitable for participation in the trial by the investigator for other reasons, or those who withdraw from the trial for their own reasons.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Affiliated hospital of Jiangnan University

    Wuxi, Jiangsu, 214000, China

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