Solid TumorPhase 1NCT05109832
A Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 to China Healthy Male Subjects
A Phase 1 study testing 14C-IMP4297 in people with Solid Tumor, run by Impact Therapeutics, Inc. at 1 site in China.
Trial summary
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor
- What is being tested?
- 14C-IMP4297
- 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
- 9 Oct 2021to 6 Dec 2021
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers must meet all of the following inclusion criteria to be included in the study:
- Volunteers must fully understand the objective, nature, methods and possible adverse reactions of the trial, volunteer to be volunteers, and sign an informed consent form before the start of any study procedures, and at the same time guarantee that the volunteers will personally participate in the study during any procedures.
- Chinese healthy male volunteers aged between 18 and 55 (including cut-off values) at the time of screening.
- Volunteers with a body mass index (BMI) of 18.0-28.0 kg/m2 (including cut-off values), and a body weight of ≥ 50.0 kg.
Who cannot join
- Volunteers who meet any of the following criteria cannot be included in this study:
- Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bones.
- A history of allergic diseases (including drug allergies and food allergies, etc.).
- A history of any gastrointestinal diseases that will affect drug absorption such as dysphagia, irritable bowel syndrome, and inflammatory bowel disease; active hemorrhoids or perianal diseases accompanied by regular/current blood in the stool; habitual constipation or diarrhea.
- Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, metabolism, or excretion.
- Those who cannot tolerate venipuncture, and those who have a history of needke sickness and blood phobia.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: A Clinical Trial of the Absorption, Metabolism, and Excretion of [14C]IMP4297 in Chinese Adult Male Healthy Volunteers - A Human Material Balance and Biotransformation Study of [14C]IMP4297
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects
Read the detailed description
Study design A Phase I, single-center, open-label, single arm study is designed to evaluate Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects.
6-8 subjects are planned to be enrolled (at least 6 subjects complete the study)
- Conditions
- Solid Tumor
- Being tested
- 14C-IMP4297
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-IMP4297Drug
14C marked IMP4297
| Study group | Role | What they receive |
|---|---|---|
| 14C-IMP4297 | Experimental | In this study, one 100 mg dose of 14C IMP4297 Oral Suspension, 100 mg (100 μCi). Receives: Drug: 14C-IMP4297 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum concentration)
peak concentration
Measured: 3 months
Tmax
Time to peak
Measured: 3 months
AUC0-inf (Area under the curve from time 0 to infinity)
area under the curve from time zero to infinity
Measured: 3 months
AUC0-last (Area under the curve from time 0 to the last time with quantifiable concentration)
AUC0-last area under the curve from time zero to the time with the last quantifiable concentration
Measured: 3 months
t½ (Elimination half-life)
elimination half-life
Measured: 3 months
CL/F (Apparent clearance)
apparent clearance
Measured: 3 months
Vz/F (apparent volume of distribution )
apparent volume of distribution
Measured: 3 months
urine and fecal samples for quantification analysis
Assessment of recovery percent in urine and feces by liquid chromatography-radiochemical-detection。 Get Percent (%) of each radiolabeled drug-related material will be determined in urine and feces
Measured: 3 months
After oral administration of [14C] IMP4297 in healthy volunteers, radioactive metabolite spectrogram are obtained to identify the main metabolites and clarify the main biotransformation pathways.
Proportion of different metabolites，Assessment of metabolites (metabolites identification and main metabolites) in plasma/urine/faeces by liquid chromatography-radiochemical-detection
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start9 Oct 2021
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impact Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109832
- Sponsor's protocol ID
- IMP4297-109
- Status last verified
- Sep 2025
- First submitted
- 12 Oct 2021
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of the Absorption, Metabolism, and Excretion of [14C]IMP4297 in Chinese Adult Male Healthy Volunteers - A Human Material Balance and Biotransformation Study of [14C]IMP4297
- ClinicalTrials.gov ID
- NCT05109832
- Acronym / sponsor ID
- IMP4297-109
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Impact Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 5 Nov 2021 (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.
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects
Detailed description
Study design A Phase I, single-center, open-label, single arm study is designed to evaluate Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects.
6-8 subjects are planned to be enrolled (at least 6 subjects complete the study)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-IMP4297 | Experimental | Drug: 14C-IMP4297In this study, one 100 mg dose of 14C IMP4297 Oral Suspension, 100 mg (100 μCi). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteers must meet all of the following inclusion criteria to be included in the study:
Key exclusion criteria (6 listed)
- Volunteers who meet any of the following criteria cannot be included in this study:
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 |
|---|---|---|
| 14C-IMP429714C marked IMP4297 | Drug | 14C-IMP4297 |
Primary outcome
Cmax (Maximum concentration)
Time frame: 3 months
peak concentration
Tmax
Time frame: 3 months
Time to peak
AUC0-inf (Area under the curve from time 0 to infinity)
Time frame: 3 months
area under the curve from time zero to infinity
AUC0-last (Area under the curve from time 0 to the last time with quantifiable concentration)
Time frame: 3 months
AUC0-last area under the curve from time zero to the time with the last quantifiable concentration
t½ (Elimination half-life)
Time frame: 3 months
elimination half-life
CL/F (Apparent clearance)
Time frame: 3 months
apparent clearance
Vz/F (apparent volume of distribution )
Time frame: 3 months
apparent volume of distribution
urine and fecal samples for quantification analysis
Time frame: 3 months
Assessment of recovery percent in urine and feces by liquid chromatography-radiochemical-detection。 Get Percent (%) of each radiolabeled drug-related material will be determined in urine and feces
After oral administration of [14C] IMP4297 in healthy volunteers, radioactive metabolite spectrogram are obtained to identify the main metabolites and clarify the main biotransformation pathways.
Time frame: 3 months
Proportion of different metabolites，Assessment of metabolites (metabolites identification and main metabolites) in plasma/urine/faeces by liquid chromatography-radiochemical-detection
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 16 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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 14C-IMP4297 in people with Solid Tumor, run by Impact Therapeutics, Inc. 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 6 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 Sep 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?
Cmax (Maximum concentration) (time frame: 3 months). The study lists 9 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 16 Sep 2025.