HealthyPhase 1NCT07693218
A Study in Healthy Men to Test How BI 1815368 is Processed in the Body
A Phase 1 study testing BI 1815368 (C-14) and BI 1815368 (C-13) in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.
Trial summary
The main objectives are: To assess mass balance by determining the extent of recovery of total [¹⁴C]-radioactivity in urine and faeces after a single oral dose administration of BI 1815368 (C-14) (test treatment T) in healthy male trial participants. 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
- Healthy
- What is being tested?
- BI 1815368 (C-14) and BI 1815368 (C-13)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Jul 2026to 4 Sep 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male trial participant as determined by 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) at screening
- Body mass index (BMI) of 18.5 to 29.9 kg / m2 (inclusive) at screening
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-related procedure
Who cannot join
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as assessed by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
- Any laboratory value outside the reference range as judged by the investigator
- Any evidence of a concomitant disease considered clinically relevant by the investigator Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Human Absorption, Distribution, Metabolism and Excretion (hADME) and Absolute Bioavailability Trial After a Single Micro-tracer Dose of BI 1815368 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1815368 (C-13) in Healthy Male Trial Participants (a Phase I, Open-label, Non Randomised, Single-dose, Fixed-sequence Trial)
The main objectives are:
- To assess mass balance by determining the extent of recovery of total [¹⁴C]-radioactivity in urine and faeces after a single oral dose administration of BI 1815368 (C-14) (test treatment T) in healthy male trial participants.
- To investigate the absolute bioavailability of BI 1815368 using a single, concomitant intravenous micro-dose administration of BI 1815368 (C13) (reference treatment R).
- To provide plasma, urine, and faecal samples
- Conditions
- Healthy
- Being tested
- BI 1815368 (C-14), BI 1815368 (C-13)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1815368 (C-14)Drug
Unlabeled BI 1815368 mixed with [C-14]-labeled BI 1815368
BI 1815368 (C-13)Drug
[13C]-labeled BI 1815368
| Study group | Role | What they receive |
|---|---|---|
| BI 1815368 (C-14) (Test) followed by BI 1815368 (C-13) (Reference) | Experimental | Not described Receives: Drug: BI 1815368 (C-14); Drug: BI 1815368 (C-13) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine,0-tz)
Measured: Up to 24 days
Fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces,0-tz)
Measured: Up to 24 days
Sum of fe urine,0-tz and fe faeces,0-tz (total recovery of [14C]-radioactivity)
Measured: Up to 24 days
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), after oral administration of BI 1815368 (C-14)
Measured: Up to 24 days
AUC0-∞ of [13C]- BI 1815368, after a concomitant IV infusion of BI 1815368 (C-13)
Measured: Up to 24 days
Secondary outcomes (6)
Maximum measured concentration of BI 1815368 in plasma (Cmax), after oral administration of BI 1815368 (C-14)
Measured: Up to 24 days
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point, after oral administration of BI 1815368 (C-14)
Measured: Up to 24 days
Cmax of [14C]-radioactivity, after oral administration of BI 1815368 (C-14)
Measured: Up to 24 days
AUC0-tz of [14C]-radioactivity, after oral administration of BI 1815368 (C-14)
Measured: Up to 24 days
Cmax of [13C]- BI 1815368
Measured: Up to 24 days
AUC0-tz of [13C]- BI 1815368
Measured: Up to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start16 Jul 2026
- Primary completion29 Aug 2026
- Study completion4 Sep 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT07693218
- Sponsor's protocol ID
- 1485-0012
- Other IDs
- 2025-523949-10, U1111-1328-2409, 2025
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2026
- Last updated
- 15 Sep 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Absorption, Distribution, Metabolism and Excretion (hADME) and Absolute Bioavailability Trial After a Single Micro-tracer Dose of BI 1815368 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1815368 (C-13) in Healthy Male Trial Participants (a Phase I, Open-label, Non Randomised, Single-dose, Fixed-sequence Trial)
- ClinicalTrials.gov ID
- NCT07693218
- Acronym / sponsor ID
- 1485-0012
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 29 Aug 2026 (actual)
- Study completion
- 4 Sep 2026 (actual)
- First posted
- 9 Jul 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.
The main objectives are:
- To assess mass balance by determining the extent of recovery of total [¹⁴C]-radioactivity in urine and faeces after a single oral dose administration of BI 1815368 (C-14) (test treatment T) in healthy male trial participants.
- To investigate the absolute bioavailability of BI 1815368 using a single, concomitant intravenous micro-dose administration of BI 1815368 (C13) (reference treatment R).
- To provide plasma, urine, and faecal samples
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 1815368 (C-14) (Test) followed by BI 1815368 (C-13) (Reference) | Experimental | Drug: BI 1815368 (C-14), Drug: BI 1815368 (C-13) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male trial participant as determined by 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) at screening
- Body mass index (BMI) of 18.5 to 29.9 kg / m2 (inclusive) at screening
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-related procedure
Key exclusion criteria (4 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as assessed by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
- Any laboratory value outside the reference range as judged by the investigator
- Any evidence of a concomitant disease considered clinically relevant 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 1815368 (C-14)Unlabeled BI 1815368 mixed with [C-14]-labeled BI 1815368 | Drug | BI 1815368 (C-14) (Test) followed by BI 1815368 (C-13) (Reference) |
| BI 1815368 (C-13)[13C]-labeled BI 1815368 | Drug | BI 1815368 (C-14) (Test) followed by BI 1815368 (C-13) (Reference) |
Primary outcome
Fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine,0-tz)
Time frame: Up to 24 days
Fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces,0-tz)
Time frame: Up to 24 days
Sum of fe urine,0-tz and fe faeces,0-tz (total recovery of [14C]-radioactivity)
Time frame: Up to 24 days
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), after oral administration of BI 1815368 (C-14)
Time frame: Up to 24 days
AUC0-∞ of [13C]- BI 1815368, after a concomitant IV infusion of BI 1815368 (C-13)
Time frame: Up to 24 days
6 secondary outcomes
Maximum measured concentration of BI 1815368 in plasma (Cmax), after oral administration of BI 1815368 (C-14)
Time frame: Up to 24 days
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point, after oral administration of BI 1815368 (C-14)
Time frame: Up to 24 days
Cmax of [14C]-radioactivity, after oral administration of BI 1815368 (C-14)
Time frame: Up to 24 days
AUC0-tz of [14C]-radioactivity, after oral administration of BI 1815368 (C-14)
Time frame: Up to 24 days
Cmax of [13C]- BI 1815368
Time frame: Up to 24 days
AUC0-tz of [13C]- BI 1815368
Time frame: Up to 24 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 15 Sep 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 1815368 (C-14) and BI 1815368 (C-13) 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 15 Sep 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?
Fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine,0-tz) (time frame: Up to 24 days). 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 15 Sep 2026.