Mass Balance StudyPhase 1NCT06671873
Study on Mass Balance of [14C]HMPL-306（Isocitrate Dehydrogenase Inhibitor） in Healthy Chinese Adult Male Subjects
A Phase 1 study testing 100 µCi [14C] HMPL-306 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-306 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?
- 100 µCi [14C] HMPL-306
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2024to 2 Jul 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
- Subjects are fully informed about the contents, procedures and possible adverse reactions of the study, voluntarily sign the informed consent form, and are able to communicate well with investigators and to complete all study procedures specified in the protocol;
- Healthy male subjects who are 18 to 45 years (inclusive) at the time of signing the informed consent form.;
- Weight ≥50 kg, and body mass index (BMI) between 19 - 26 kg/m2 (inclusive);
- Subjects must promise to have no pregnancy plan or sperm donation plan and to use condoms during sexual intercourse from signing the informed consent form until 180 days after end of the study treatment. If the sexual partner is a female of childbearing potential, a highly effective method of contraception should be also used (see Appendix 1 for more information).
Who cannot join
- History of serious allergy (e.g., drug allergy) and acute allergic rhinitis or food allergy within two weeks prior to screening;
- Subjects with a history or clinical manifestation of clinically significant metabolic/endocrine, hepatic, renal, hematologic, pulmonary, immunologic, cardiovascular, gastrointestinal, genitourinary, neurologic, or psychiatric diseases within 3 months prior to and during the screening period (judged by investigators);
- Previous history of hypertension;
- Subjects who are positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody, or anti-treponema pallidum antibody;
- Smoking more than 10 cigarettes daily within 3 months prior to the screening and inability to refrain from smoking completely during the study period;
- Regular alcohol consumption within 6 months prior to the study, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or positive alcohol breath at screening;
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- Presence of drug abuse or dependence, or positive urine screen for drugs of abuse;
- Subjects who have poor venous access, and have a fear of needles, hemophobia or difficulty in blood collection;
- Having participated in clinical trials for other drugs within 3 months prior to the screening;
- Workers who need to be exposed to radioactive condition for a long term; or those who have significant radiation exposure (≥2 times of chest/abdominal computerised tomography (CT), or ≥3 times of other kinds of X-ray examinations) within 1 year prior to administration, or have participated in the radiopharmaceutical labeling study;
- Subjects who have been vaccinated within 30 days prior to administration and who have a plan for vaccination within 2 weeks after administration;
- According to the investigator's judgment, the subjects have any other disease or status that may affect the normal completion of the study or the evaluation of the study data, or have any other condition that is not suitable for the 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
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 250 mg/100 µCi [14C] HMPL-306
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HMPL-306
Read the detailed description
- To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]HMPL-306 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-306 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-306, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the distribution of total radioactivity in whole blood and plasma;
- Conditions
- Mass Balance Study
- Being tested
- 100 µCi [14C] HMPL-306
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 µCi [14C] HMPL-306Drug
Also called 100 µCi [14C] HMPL-306 suspension
D1: 250 mg/100 µCi [14C] HMPL-306 Single dose
| Study group | Role | What they receive |
|---|---|---|
| 100 µCi [14C] HMPL-306 | Experimental | After an overnight fasting of at least 10 hours, subjects will receive [14C] HMPL-306 containing 250 mg HMPL-306 (approximately 100 μCi radioactivity) 30 minutes after start of breakfast (must be completed within 30 minutes) and ensure that all of the drug is taken within 10 minutes. Receives: Drug: 100 µCi [14C] HMPL-306 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Mass Balance
Recovery and cumulative recovery of total radioactivity in excreta (urine and feces).
Measured: Day1~Day29
Human Mass Balance
Percentage of the unchanged drug and its metabolites in plasma to total radioactivity exposure levels in plasma;
Measured: Day-1~Day29
Human Mass Balance
Percentage of the unchanged drug and its metabolites in urine and feces to the administered dose;
Measured: Day-1~Day29
Human Mass Balance
Identification of major metabolites in plasma, urine and feces.
Measured: Day-1~Day29
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~Day29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start26 Nov 2024
- Primary completion28 Feb 2025
- Study completion2 Jul 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
- Investigators
- Wei Zhao, offices director, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671873
- Sponsor's protocol ID
- 2024-306-00CH1
- Status last verified
- Jul 2025
- First submitted
- 29 Oct 2024
- Last updated
- 31 Jul 2025
- 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 31 Jul 2025. 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 250 mg/100 µCi [14C] HMPL-306
- ClinicalTrials.gov ID
- NCT06671873
- Acronym / sponsor ID
- 2024-306-00CH1
- 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 Nov 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 4 Nov 2024 (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-306
Detailed description
- To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]HMPL-306 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-306 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-306, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the distribution of total radioactivity in whole blood and plasma;
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 |
|---|---|---|
| 100 µCi [14C] HMPL-306 | Experimental | Drug: 100 µCi [14C] HMPL-306After an overnight fasting of at least 10 hours, subjects will receive [14C] HMPL-306 containing 250 mg HMPL-306 (approximately 100 μCi radioactivity) 30 minutes after start of breakfast (must be completed within 30 minutes) and ensure that all of the drug 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)
- Subjects are fully informed about the contents, procedures and possible adverse reactions of the study, voluntarily sign the informed consent form, and are able to communicate well with investigators and to complete all study procedures specified in the protocol;
- Healthy male subjects who are 18 to 45 years (inclusive) at the time of signing the informed consent form.;
- Weight ≥50 kg, and body mass index (BMI) between 19 - 26 kg/m2 (inclusive);
- Subjects must promise to have no pregnancy plan or sperm donation plan and to use condoms during sexual intercourse from signing the informed consent form until 180 days after end of the study treatment. If the sexual partner is a female of childbearing potential, a highly effective method of contraception should be also used (see Appendix 1 for more information).
Key exclusion criteria (12 listed)
- History of serious allergy (e.g., drug allergy) and acute allergic rhinitis or food allergy within two weeks prior to screening;
- Subjects with a history or clinical manifestation of clinically significant metabolic/endocrine, hepatic, renal, hematologic, pulmonary, immunologic, cardiovascular, gastrointestinal, genitourinary, neurologic, or psychiatric diseases within 3 months prior to and during the screening period (judged by investigators);
- Previous history of hypertension;
- Subjects who are positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody, or anti-treponema pallidum antibody;
- Smoking more than 10 cigarettes daily within 3 months prior to the screening and inability to refrain from smoking completely during the study period;
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 |
|---|---|---|
| 100 µCi [14C] HMPL-306Also: 100 µCi [14C] HMPL-306 suspensionD1: 250 mg/100 µCi [14C] HMPL-306 Single dose | Drug | 100 µCi [14C] HMPL-306 |
Primary outcome
Human Mass Balance
Time frame: Day1~Day29
Recovery and cumulative recovery of total radioactivity in excreta (urine and feces).
Human Mass Balance
Time frame: Day-1~Day29
Percentage of the unchanged drug and its metabolites in plasma to total radioactivity exposure levels in plasma;
Human Mass Balance
Time frame: Day-1~Day29
Percentage of the unchanged drug and its metabolites in urine and feces to the administered dose;
Human Mass Balance
Time frame: Day-1~Day29
Identification of major metabolites in plasma, urine and feces.
Human Mass Balance
Time frame: Day-1~Day29
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 31 Jul 2025.
- 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.
Wei Zhao, offices director principal investigator
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
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 100 µCi [14C] HMPL-306 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 12 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 31 Jul 2025. 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: Day1~Day29). The study lists 5 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 31 Jul 2025.