Mass Balance StudyPhase 1NCT07644442
Study on [14C]HMPL-453（FGFR Inhibitor） in Healthy Chinese Adult Male Subjects
A Phase 1 study testing HMPL-453 in people with Mass Balance Study, run by Hutchmed at 1 site in China.
Trial summary
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HMPL-453 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
- Mass Balance Study
- What is being tested?
- HMPL-453
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2025to 14 Mar 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
- The subjects fully understand the content of the experiment, the process and possible adverse reactions, voluntarily sign the informed consent form, can communicate well with the researchers, and can complete all experimental procedures as specified in the protocol;
- Healthy male subjects aged 18-45 years (inclusive, based on the time of signing the informed consent form);
- Body weight ≥50 kg, body mass index (BMI) 19~26 kg/m2 (including limit values);
- Subjects must commit to having no plans for pregnancy or sperm donation from the time of signing the informed consent form until 180 days after the end of the study medication administration. If the sexual partner is a female of childbearing potential, then a highly effective method of contraception should also be used.
Who cannot join
- History of severe allergies (such as drug allergies) and acute allergic rhinitis or food allergies within 2 weeks prior to screening, allergic to any investigational drug (or its excipients) given in this study;
- History of hypertension, or baseline blood pressure: systolic ≥140 mmHg and/or diastolic ≥90 mmHg;
- Existing or occurring during the screening period clinically abnormal manifestations that need to be excluded (as judged by the researcher), including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular system, digestive system (any history of gastrointestinal diseases affecting oral or absorption of drugs), blood and lymphatic system, urinary system, endocrine system, immune system;
- History of gastrointestinal surgery, kidney surgery, cholecystectomy, etc., which the researchers judge may affect drug absorption or excretion;
- Abnormal ophthalmological examination results have clinical significance, corrected visual acuity <1.0 or with the following history of eye diseases: non-arteritic anterior ischemic optic neuropathy (NAION), color vision abnormalities, hereditary retinal degeneration (such as pigmentary retinopathy), macular degeneration, retinal detachment, corneal lesions confirmed by ophthalmological examination, including but not limited to bullous keratopathy, band keratopathy, corneal abrasion, corneal ulcer, keratitis, etc.;
- Anal diseases with periodic/ongoing bleeding;
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- History of vomiting and diarrhea within the past week;
- Subjects who have used any prescription drugs within the past 30 days;
- History of any non-prescription drugs and herbal supplements (including but not limited to vitamins, preventive treatments, Chinese herbal medicines, plant-based health products, etc.) taken within the past 14 days;
- Screening period vital signs, physical examination, chest frontal and lateral films, and laboratory tests (including routine blood tests, blood biochemistry, routine urine tests, thyroid function, coagulation function, stool analysis, etc.) results are judged by the researcher to be clinically significant abnormalities (CS);
- During the screening period, clinically significant abnormalities appear on the 12-lead ECG, or baseline QTcF interval >450 ms, or there is a history of QTc interval prolongation syndrome or sudden death in the family. If the ECG cannot display the QTcF result, please use the following formula to calculate: QTcF=QT/∛RR (RR=60/heart rate);
- Creatinine clearance rate ≤90 mL/min estimated by the Cockcroft-Gault formula [(140-age) × weight (kg)] / [72 × serum creatinine (mg/dL)];
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody, or syphilis spirochete antibody;
- Irregular or difficult bowel movements, or other conditions that the researcher determines may affect stool sample collection;
- Subjects who smoked more than 10 cigarettes per day in the past 3 months, and could not completely quit smoking during the study period;
- Frequent drinkers in the past 6 months, i.e., those who drink more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL 40% alcohol spirits or 150 mL wine), or those who test positive for alcohol breath test during the screening period;
- Drug abuse or dependence, or positive urine drug abuse screening;
- Subjects consumed foods, juices or beverages containing alcohol, grapefruit, pomelo, citron, orange and caffeine within 72 hours prior to the first dose, and did not agree to abstain from them during the study period;
- Subjects who have used blood products within the past 2 months; screen for those who have donated blood (including component donation) or lost ≥400 mL of blood within the past 3 months, screen for those who have donated blood (including component donation) or lost ≥200 mL of blood within the past 1 month, or plan to donate blood or blood components during the study period or within 1 month after the end of the study;
- Poor venous blood collection assessment, fear of needles, fear of blood or difficulty in collecting venous blood;
- Having participating in other drug clinical trials within the past three months;
- Workers engaged in work that requires long-term exposure to radioactive conditions; or those who have had significant radiation exposure within 1 year prior to administration [≥2 chest/abdominal computed tomography (CT) scans, or ≥3 other types of X-ray examinations] or participated in radioactive drug labeling trials;
- Subjects who have been vaccinated within 30 days before administration, and those who plan to be vaccinated within two weeks after administration;
- According to the researchers' judgment, the subject has any other disease or condition that may affect the normal completion of the experiment or the evaluation of the research data, or any other situation that is not suitable for participating in this study. -
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250000
About this study
Official title: A Single-center, Open-label, Single-dose Phase I Clinical Study to Investigate the Human Mass Balance in Healthy Chinese Adult Male Subjects Following a Single Oral Dose of 300 mg/200 µCi [14C] HMPL-453
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HMPL-453
Read the detailed description
- To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]HMPL-453 in healthy subjects, obtain the data on human radioactivity excretion rate and determine the main excretion pathways;
- To obtain the radioactive metabolite profile in plasma, urine, and feces after oral administration of [14C]HMPL-453 in healthy subjects, to identify the main metabolites and to determine the metabolism and elimination pathways;
- To quantitatively analyze the total radioactivity in whole blood and plasma in healthy subjects after oral administration of [14C]HMPL-453, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the ratio of total radioactivity concentration in whole blood/plasma at different time points;
- Conditions
- Mass Balance Study
- Being tested
- HMPL-453
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-453Drug
D1: 300 mg/200 µCi [14C] HMPL-453 Single dose
| Study group | Role | What they receive |
|---|---|---|
| 200µCi [14C] HMPL-453 | Experimental | After an overnight fast of at least 10 hours, subjects will take [14C]HMPL-453 (approximately 200 μCi radioactivity) containing 300 mg HMPL-453 30 minutes after starting breakfast (breakfast must be finished within 30 minutes), and ensure that the entire dose is taken within 10 minutes. Receives: Drug: HMPL-453 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Mass balance
The recovery and cumulative recovery of total radioactivity in excreta (urine and feces).
Measured: Day-1 ~Day15
Human Mass balance
Percentage of the unchanged drug and its metabolites in plasma to total radioactivity exposure levels in plasma; percentage of the unchanged drug and its metabolites in urine and feces to the administered dose; identification of major metabolites in plasma, urine and feces.
Measured: Day-1 ~Day15
Human Mass balance
PK parameters of total radioactivity in the plasma; Ratio of total radioactivity concentration in whole blood/plasma at different time points.
Measured: Day-1 ~Day15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start26 Feb 2025
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mass Balance StudyStudies of the same condition, open and under way.
- More trials run by HutchmedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644442
- Sponsor's protocol ID
- 2024-453-00CH2
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Single-dose Phase I Clinical Study to Investigate the Human Mass Balance in Healthy Chinese Adult Male Subjects Following a Single Oral Dose of 300 mg/200 µCi [14C] HMPL-453
- ClinicalTrials.gov ID
- NCT07644442
- Acronym / sponsor ID
- 2024-453-00CH2
- Conditions
- Mass Balance Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HMPL-453
Detailed description
- To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]HMPL-453 in healthy subjects, obtain the data on human radioactivity excretion rate and determine the main excretion pathways;
- To obtain the radioactive metabolite profile in plasma, urine, and feces after oral administration of [14C]HMPL-453 in healthy subjects, to identify the main metabolites and to determine the metabolism and elimination pathways;
- To quantitatively analyze the total radioactivity in whole blood and plasma in healthy subjects after oral administration of [14C]HMPL-453, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the ratio of total radioactivity concentration in whole blood/plasma at different time points;
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 200µCi [14C] HMPL-453 | Experimental | Drug: HMPL-453After an overnight fast of at least 10 hours, subjects will take [14C]HMPL-453 (approximately 200 μCi radioactivity) containing 300 mg HMPL-453 30 minutes after starting breakfast (breakfast must be finished within 30 minutes), and ensure that the entire dose is taken within 10 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subjects fully understand the content of the experiment, the process and possible adverse reactions, voluntarily sign the informed consent form, can communicate well with the researchers, and can complete all experimental procedures as specified in the protocol;
- Healthy male subjects aged 18-45 years (inclusive, based on the time of signing the informed consent form);
- Body weight ≥50 kg, body mass index (BMI) 19~26 kg/m2 (including limit values);
- Subjects must commit to having no plans for pregnancy or sperm donation from the time of signing the informed consent form until 180 days after the end of the study medication administration. If the sexual partner is a female of childbearing potential, then a highly effective method of contraception should also be used.
Key exclusion criteria (24 listed)
- History of severe allergies (such as drug allergies) and acute allergic rhinitis or food allergies within 2 weeks prior to screening, allergic to any investigational drug (or its excipients) given in this study;
- History of hypertension, or baseline blood pressure: systolic ≥140 mmHg and/or diastolic ≥90 mmHg;
- Existing or occurring during the screening period clinically abnormal manifestations that need to be excluded (as judged by the researcher), including but not limited to diseases of the nervous/mental system, respiratory system, cardiovascular system, digestive system (any history of gastrointestinal diseases affecting oral or absorption of drugs), blood and lymphatic system, urinary system, endocrine system, immune system;
- History of gastrointestinal surgery, kidney surgery, cholecystectomy, etc., which the researchers judge may affect drug absorption or excretion;
- Abnormal ophthalmological examination results have clinical significance, corrected visual acuity <1.0 or with the following history of eye diseases: non-arteritic anterior ischemic optic neuropathy (NAION), color vision abnormalities, hereditary retinal degeneration (such as pigmentary retinopathy), macular degeneration, retinal detachment, corneal lesions confirmed by ophthalmological examination, including but not limited to bullous keratopathy, band keratopathy, corneal abrasion, corneal ulcer, keratitis, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMPL-453D1: 300 mg/200 µCi [14C] HMPL-453 Single dose | Drug | 200µCi [14C] HMPL-453 |
Primary outcome
Human Mass balance
Time frame: Day-1 ~Day15
The recovery and cumulative recovery of total radioactivity in excreta (urine and feces).
Human Mass balance
Time frame: Day-1 ~Day15
Percentage of the unchanged drug and its metabolites in plasma to total radioactivity exposure levels in plasma; percentage of the unchanged drug and its metabolites in urine and feces to the administered dose; identification of major metabolites in plasma, urine and feces.
Human Mass balance
Time frame: Day-1 ~Day15
PK parameters of total radioactivity in the plasma; Ratio of total radioactivity concentration in whole blood/plasma at different time points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HMPL-453 in people with Mass Balance Study, run by Hutchmed 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 24 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 12 Jun 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?
Human Mass balance (time frame: Day-1 ~Day15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.