HealthyPhase 1NCT07273474
A Study in Healthy Men and Women to Test How BI 3000202 is Taken up and Processed by the Body
A Phase 1 study testing BI 3000202 and BI 3000202 [14C]-labelled in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.
Trial summary
The purpose of this study is to find out how quickly and to what extent BI 3000202 is processed in the body. The purpose of Part A is to find out how 3000202 moves through and exits the body of healthy people. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 3000202 and BI 3000202 [14C]-labelled
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Dec 2025to 25 Mar 2026
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female of non-childbearing potential trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 55 years (inclusive)
- Body mass index (BMI) of 18.5 to 30 kg/m² (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg (inclusive), diastolic blood pressure outside the range of 50 to 90 mmHg (inclusive), or pulse rate outside the range of 40 to 99 bpm (inclusive)
- Any laboratory value outside the reference range that the investigator considers to be of clinical significance
- Any evidence of a concomitant disease assessed as clinically significant by the investigator Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label Trial in Two Parallel Parts to Investigate Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 3000202 (C-14) Administered as Oral Solution (Part A) and to Investigate Absolute Bioavailability (BA) of BI 3000202 Administered as Film Coated Tablet Together With an Intravenous Microtracer Dose of BI 3000202 (C-14) (Part B) in Healthy Male and Female Participants
The purpose of this study is to find out how quickly and to what extent BI 3000202 is processed in the body.
The purpose of Part A is to find out how 3000202 moves through and exits the body of healthy people. The purpose of Part B is to find out how much BI 3000202 gets into the blood when participants take it as a tablet compared with when they get it as an infusion.
Adults between 18 and 55 years of age can take part if the study doctor determines they are healthy.
The doctors regularly check participants' health. To assess the study endpoints, the study staff takes blood, urine, and stool samples.
- Conditions
- Healthy
- Being tested
- BI 3000202, BI 3000202 [14C]-labelled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3000202Drug
BI 3000202 unlabelled
BI 3000202 [14C]-labelledDrug
BI 3000202 [14C]-labelled
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Absorption, distribution, metabolism, and excretion (ADME) Receives: Drug: BI 3000202; Drug: BI 3000202 [14C]-labelled |
| Part B | Experimental | Bioavailability (BA) Receives: Drug: BI 3000202; Drug: BI 3000202 [14C]-labelled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: fe-urine, 0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
Measured: up to 21 days
Part A: fe-faeces, 0-tz (fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
Measured: up to 21 days
Part B: AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity)
Measured: up to 6 days
Secondary outcomes (4)
Part A: Cmax (maximum measured concentration of the analyte)
Measured: up to 20 days
Part A: AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point)
Measured: up to 20 days
Part B: Cmax
Measured: up to 6 days
Part B: AUC0-tz
Measured: up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start30 Dec 2025
- Primary completion5 Mar 2026
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273474
- Sponsor's protocol ID
- 1509-0010
- Other IDs
- 2023-510345-21-00, U1111-1301-4856, 2023
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Trial in Two Parallel Parts to Investigate Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 3000202 (C-14) Administered as Oral Solution (Part A) and to Investigate Absolute Bioavailability (BA) of BI 3000202 Administered as Film Coated Tablet Together With an Intravenous Microtracer Dose of BI 3000202 (C-14) (Part B) in Healthy Male and Female Participants
- ClinicalTrials.gov ID
- NCT07273474
- Acronym / sponsor ID
- 1509-0010
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 9 Dec 2025 (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.
The purpose of this study is to find out how quickly and to what extent BI 3000202 is processed in the body.
The purpose of Part A is to find out how 3000202 moves through and exits the body of healthy people. The purpose of Part B is to find out how much BI 3000202 gets into the blood when participants take it as a tablet compared with when they get it as an infusion.
Adults between 18 and 55 years of age can take part if the study doctor determines they are healthy.
The doctors regularly check participants' health. To assess the study endpoints, the study staff takes blood, urine, and stool samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: BI 3000202, Drug: BI 3000202 [14C]-labelledAbsorption, distribution, metabolism, and excretion (ADME) |
| Part B | Experimental | Drug: BI 3000202, Drug: BI 3000202 [14C]-labelledBioavailability (BA) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female of non-childbearing potential trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 55 years (inclusive)
- Body mass index (BMI) of 18.5 to 30 kg/m² (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Key exclusion criteria (4 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg (inclusive), diastolic blood pressure outside the range of 50 to 90 mmHg (inclusive), or pulse rate outside the range of 40 to 99 bpm (inclusive)
- Any laboratory value outside the reference range that the investigator considers to be of clinical significance
- Any evidence of a concomitant disease assessed as clinically significant by the investigator Further exclusion criteria apply.
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 |
|---|---|---|
| BI 3000202BI 3000202 unlabelled | Drug | Part A, Part B |
| BI 3000202 [14C]-labelledBI 3000202 [14C]-labelled | Drug | Part A, Part B |
Primary outcome
Part A: fe-urine, 0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
Time frame: up to 21 days
Part A: fe-faeces, 0-tz (fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
Time frame: up to 21 days
Part B: AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity)
Time frame: up to 6 days
4 secondary outcomes
Part A: Cmax (maximum measured concentration of the analyte)
Time frame: up to 20 days
Part A: AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point)
Time frame: up to 20 days
Part B: Cmax
Time frame: up to 6 days
Part B: AUC0-tz
Time frame: up to 6 days
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 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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 BI 3000202 and BI 3000202 [14C]-labelled in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.
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 4 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 Mar 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 Netherlands. 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?
Part A: fe-urine, 0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point) (time frame: up to 21 days). 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 31 Mar 2026.