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Healthy Adult MalePhase 1NCT07211165

Clinical Study on the Mass Balance of Clifutinib

A Phase 1 study testing [14C]Clifutinib in people with Healthy Adult Male, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Adult Male
What is being tested?
[14C]Clifutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
29 Sep 2025to 12 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Those with lactose intolerance (those who have experienced diarrhea after drinking milk).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Those who have received vaccinations within one month before screening or plan to receive vaccinations during the trial period.
  • 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).
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated hospital of Jiangnan University

    Wuxi, Jiangsu, 214000

Other trials in China

About this study

Official title: Study on the Mass Balance of [14C] Clifutinib in Chinese Male Healthy Subjects

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.

Being tested
[14C]Clifutinib
Keywords
Clifutinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]ClifutinibDrug

    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.

Study groups in NCT07211165
Study groupRoleWhat they receive
[14C]ClifutinibExperimentalOn Day 1, subjects will receive a single oral dose of 40 mg/100 µCi [14C]Clifutinib
Receives: Drug: [14C]Clifutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-∞

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

    Measured: From Day 1 of dosing to the Day 85 after dosing

  2. Tmax

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

    Measured: From Day 1 of dosing to the Day 85 after dosing

  3. Cmax

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

    Measured: From Day 1 of dosing to the Day 85 after dosing

  4. 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.

    Measured: From Day 1 of dosing to the Day 85 after dosing

  5. 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.

    Measured: From Day 1 of dosing to the Day 85 after dosing

  6. 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.

    Measured: From Day 1 of dosing to the Day 85 after dosing

Secondary outcomes (4)

  1. AUC0-∞

    The validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to quantitatively analyze the concentrations of Clifutinib, its metabolite (M3), and other metabolites (if applicable) in plasma, thereby obtaining the corresponding pharmacokinetic parameters.

    Measured: From Day 1 of dosing to the Day 85 after dosing

  2. Tmax

    The validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to quantitatively analyze the concentrations of Clifutinib, its metabolite (M3), and other metabolites (if applicable) in plasma, thereby obtaining the corresponding pharmacokinetic parameters.

    Measured: From Day 1 of dosing to the Day 85 after dosing

  3. Cmax

    The validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to quantitatively analyze the concentrations of Clifutinib, its metabolite (M3), and other metabolites (if applicable) in plasma, thereby obtaining the corresponding pharmacokinetic parameters.

    Measured: From Day 1 of dosing to the Day 85 after dosing

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

    Observation of the safety profile in male healthy subjects after a single administration of [14C] Clifutinib

    Measured: From Day 1 of dosing to the Day 85 after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2025
  2. Study start29 Sep 2025
  3. Primary completion5 Nov 2025
  4. Study completion12 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07211165
Sponsor's protocol ID
HEC73543-AML-104
Status last verified
Sep 2025
First submitted
22 Sep 2025
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]Clifutinib in people with Healthy Adult Male, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-∞ (time frame: From Day 1 of dosing to the Day 85 after dosing). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07211165.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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