HealthyPhase 1NCT07336758
A Study in Healthy Men to Test How BI 1584862 is Processed in the Body
A Phase 1 study testing [13C]-labeled BI 1584862 and Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862 in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.
Trial summary
The goal of this study is to find out how BI 1584862 moves through and exits the body of healthy men. To do this, BI 1584862 is labelled using radioactive carbon (C-14) and using a non-radioactive, naturally occurring, stable isotope (C-13). 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?
- [13C]-labeled BI 1584862 and Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jan 2026to 4 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male trial participant 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) at screening
- 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 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, 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 that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as 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 1584862 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1584862 (C-13) in Healthy Male Trial Participants (a Phase I, Open-label, Non-randomised, Single-dose, Fixed-sequence Trial)
The goal of this study is to find out how BI 1584862 moves through and exits the body of healthy men. To do this, BI 1584862 is labelled using radioactive carbon (C-14) and using a non-radioactive, naturally occurring, stable isotope (C-13). The study will measure how much of the study medicine is recovered in urine and faeces after taking it by mouth. It will also look at how much of the study medicine enters the bloodstream when taken by mouth compared to a small dose given directly into the bloodstream. The study staff measures the amount of BI 1584862 and its broken-down parts in the blood, the urine, and the stool.
- Conditions
- Healthy
- Being tested
- [13C]-labeled BI 1584862, Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[13C]-labeled BI 1584862Drug
[13C]-labeled BI 1584862, Reference treatment
Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862Drug
BI 1584862 (C-14), Test treatment
| Study group | Role | What they receive |
|---|---|---|
| BI 1584862 (C-14) (Test treatment) followed by [13C]-labeled BI 1584862 (Reference treatment) | Experimental | Not described Receives: Drug: [13C]-labeled BI 1584862; Drug: Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz)
hADME part
Measured: Up to Day 14
Fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces,0-tz)
hADME part
Measured: Up to Day 14
Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity)
hADME part
Measured: Up to Day 14
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) (AUC0-∞)
BA part
Measured: Up to day 13
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of [13C]-BI 1584862 after a single intravenous infusion of BI 1584862 (C-13) (AUC0-∞)
BA part
Measured: Up to Day 6
Secondary outcomes (6)
Cmax (maximum measured concentration of the analyte in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)
hADME and BA part
Measured: Up to Day 13
AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)
hADME and BA part
Measured: Up to Day 13
Cmax of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)
hADME part
Measured: Up to Day 13
AUC0-tz of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)
hADME part
Measured: Up to Day 13
Cmax of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)
BA part
Measured: Up to Day 6
AUC0-tz of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)
BA part
Measured: Up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start22 Jan 2026
- Primary completion4 Mar 2026
- Study completion4 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
- Not applicable
- Intervention model
- Single group
- 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
- NCT07336758
- Sponsor's protocol ID
- 1484-0017
- Other IDs
- 2025-522311-41-00, U1111-1322-4722, 2025
- Status last verified
- Jun 2026
- First submitted
- 2 Jan 2026
- Last updated
- 23 Jun 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.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 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 1584862 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1584862 (C-13) in Healthy Male Trial Participants (a Phase I, Open-label, Non-randomised, Single-dose, Fixed-sequence Trial)
- ClinicalTrials.gov ID
- NCT07336758
- Acronym / sponsor ID
- 1484-0017
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 13 Jan 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 goal of this study is to find out how BI 1584862 moves through and exits the body of healthy men. To do this, BI 1584862 is labelled using radioactive carbon (C-14) and using a non-radioactive, naturally occurring, stable isotope (C-13). The study will measure how much of the study medicine is recovered in urine and faeces after taking it by mouth. It will also look at how much of the study medicine enters the bloodstream when taken by mouth compared to a small dose given directly into the bloodstream. The study staff measures the amount of BI 1584862 and its broken-down parts in the blood, the urine, and the stool.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI 1584862 (C-14) (Test treatment) followed by [13C]-labeled BI 1584862 (Reference treatment) | Experimental | Drug: [13C]-labeled BI 1584862, Drug: Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862 |
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 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) at screening
- 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 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, 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 that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as 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 |
|---|---|---|
| [13C]-labeled BI 1584862[13C]-labeled BI 1584862, Reference treatment | Drug | BI 1584862 (C-14) (Test treatment) followed by [13C]-labeled BI 1584862 (Reference treatment) |
| Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862BI 1584862 (C-14), Test treatment | Drug | BI 1584862 (C-14) (Test treatment) followed by [13C]-labeled BI 1584862 (Reference treatment) |
Primary outcome
Fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz)
Time frame: Up to Day 14
hADME part
Fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces,0-tz)
Time frame: Up to Day 14
hADME part
Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity)
Time frame: Up to Day 14
hADME part
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) (AUC0-∞)
Time frame: Up to day 13
BA part
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of [13C]-BI 1584862 after a single intravenous infusion of BI 1584862 (C-13) (AUC0-∞)
Time frame: Up to Day 6
BA part
6 secondary outcomes
Cmax (maximum measured concentration of the analyte in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)
Time frame: Up to Day 13
AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)
Time frame: Up to Day 13
Cmax of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)
Time frame: Up to Day 13
AUC0-tz of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)
Time frame: Up to Day 13
Cmax of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)
Time frame: Up to Day 6
AUC0-tz of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)
Time frame: Up to Day 6
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 23 Jun 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.mystudywindow.com/msw/datatransparency
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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 [13C]-labeled BI 1584862 and Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862 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 23 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 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 excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz) (time frame: Up to Day 14). 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 23 Jun 2026.