HealthyPhase 1NCT06572111
A Study in Healthy Men to Test How BI 1839100 is Taken up and Handled by the Body
A Phase 1 study testing BI 1839100 (C-14) formulation 1, BI 1839100 and BI 1839100 (C-14) formulation 2 in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.
Trial summary
This trial is conducted in healthy male subjects to evaluate the drug BI 1839100. The trial has two main parts. Part A aims to understand how BI 1839100 is processed in the body after an oral dose. It measures the total recovery of the drug and its radioactive label in urine and feces. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 1839100 (C-14) formulation 1, BI 1839100 and BI 1839100 (C-14) formulation 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Sep 2024to 2 Sep 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 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects 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 electronic cardiogram (ECG), and clinical laboratory tests.
- Age of 18 to 59 years (inclusive at screening)
- Body mass index (BMI) of 18.5 to 30.0 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 blood pressure (BP), pulse rate (PR), or ECG that deviates from normal and is assessed as clinically significant by the investigator
- Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 bpm (subjects with PR values between 45 and 50 bpm may only be enrolled in case they have normal thyroid function (thyroid-stimulating hormone (TSH) and free thyroxine (FT4) at baseline-screening, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
- 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
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically significant by the investigator
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the Pharmacokinetics (PKs) of the trial medication (except appendectomy or simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders assessed as clinically relevant by the investigator
- History of significant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label Trial to Investigate the Metabolism, Pharmacokinetics (Following a Mass Balance Design; Part A) and Absolute Bioavailability of BI 1839100 (C-14) After Oral and Intravenous Administration (Part B) in Healthy Male Subjects
This trial is conducted in healthy male subjects to evaluate the drug BI 1839100. The trial has two main parts. Part A aims to understand how BI 1839100 is processed in the body after an oral dose. It measures the total recovery of the drug and its radioactive label in urine and feces. It also determines the concentrations in blood plasma and investigates the drug's metabolic pathways. Part B aims to compare the absolute bioavailability of BI 1839100 when administered orally and intravenously.
- Conditions
- Healthy
- Being tested
- BI 1839100 (C-14) formulation 1, BI 1839100, BI 1839100 (C-14) formulation 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1839100 (C-14) formulation 1Drug
BI 1839100 (C-14) formulation 1
BI 1839100Drug
BI 1839100
BI 1839100 (C-14) formulation 2Drug
BI 1839100 (C-14) formulation 2
| Study group | Role | What they receive |
|---|---|---|
| Part A: BI 1839100 (C-14) formulation 1 | Experimental | BI 1839100 (C-14) = BI 1839100 Carbon 14 Radiolabelled Receives: Drug: BI 1839100 (C-14) formulation 1 |
| Part B: BI 1839100 followed by BI 1839100 (C-14) formulation 2 | Experimental | Not described Receives: Drug: BI 1839100; Drug: BI 1839100 (C-14) formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass balance and total recovery of [C-14]-radioactivity in urine and feces.
Part A
Measured: From drug administration up to Day 21.
Area under the concentration-time curve of Carbon-14-labeled BI 1839100 after intravenous administration and BI 1839100 after oral administration, extrapolated to infinity (AUC0-∞).
Part B
Measured: From drug administration up to Day 21.
Secondary outcomes (4)
Maximum measured concentration of BI 1839100 and Carbon-14-labeled BI 1839100 in plasma (Cmax).
Part A
Measured: Two hours before drug administration up to Day 21.
Area under the concentration-time curve of BI 1839100 and Carbon-14-labeled BI 1839100 from 0 to the last quantifiable time point (AUC0-tz).
Part A
Measured: Two hours before drug administration up to Day 21.
Area under the concentration-time curve of Carbon-14-labeled BI 1839100 in plasma after intravenous administration and BI 1839100 after oral administration, from 0 to the last quantifiable time point (AUC0-tz).
Part B
Measured: Two hours before drug administration up to 72 hours (Day 4).
Maximum measured concentration of Carbon-14-labeled BI 1839100 in plasma after intravenous administration and BI 1839100 after oral administration (Cmax).
Part B
Measured: Two hours before drug administration up to 72 hours (Day 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start30 Sep 2024
- Primary completion28 Oct 2024
- Study completion2 Sep 2025
Why it stopped: Company decision
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
- Single group
- Model description
- Part A: open-label, single arm, single-dose Part B: non-randomized, open-label, single-arm, single period, fixed sequence, crossover
- 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
- NCT06572111
- Sponsor's protocol ID
- 1490-0006
- Other IDs
- 2024-510870-26-00, U1111-1308-5227
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2024
- Last updated
- 23 Sep 2025
- 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 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Trial to Investigate the Metabolism, Pharmacokinetics (Following a Mass Balance Design; Part A) and Absolute Bioavailability of BI 1839100 (C-14) After Oral and Intravenous Administration (Part B) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06572111
- Acronym / sponsor ID
- 1490-0006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 26 Aug 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.
This trial is conducted in healthy male subjects to evaluate the drug BI 1839100. The trial has two main parts. Part A aims to understand how BI 1839100 is processed in the body after an oral dose. It measures the total recovery of the drug and its radioactive label in urine and feces. It also determines the concentrations in blood plasma and investigates the drug's metabolic pathways. Part B aims to compare the absolute bioavailability of BI 1839100 when administered orally and intravenously.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part A: open-label, single arm, single-dose Part B: non-randomized, open-label, single-arm, single period, fixed sequence, crossover
| Arm | Type | Receives |
|---|---|---|
| Part A: BI 1839100 (C-14) formulation 1 | Experimental | Drug: BI 1839100 (C-14) formulation 1BI 1839100 (C-14) = BI 1839100 Carbon 14 Radiolabelled |
| Part B: BI 1839100 followed by BI 1839100 (C-14) formulation 2 | Experimental | Drug: BI 1839100, Drug: BI 1839100 (C-14) formulation 2 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects 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 electronic cardiogram (ECG), and clinical laboratory tests.
- Age of 18 to 59 years (inclusive at screening)
- Body mass index (BMI) of 18.5 to 30.0 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 (8 listed)
- Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), or ECG that deviates from normal and is assessed as clinically significant by the investigator
- Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 bpm (subjects with PR values between 45 and 50 bpm may only be enrolled in case they have normal thyroid function (thyroid-stimulating hormone (TSH) and free thyroxine (FT4) at baseline-screening, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
- 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
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically significant by the investigator
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 1839100 (C-14) formulation 1BI 1839100 (C-14) formulation 1 | Drug | Part A: BI 1839100 (C-14) formulation 1 |
| BI 1839100BI 1839100 | Drug | Part B: BI 1839100 followed by BI 1839100 (C-14) formulation 2 |
| BI 1839100 (C-14) formulation 2BI 1839100 (C-14) formulation 2 | Drug | Part B: BI 1839100 followed by BI 1839100 (C-14) formulation 2 |
Primary outcome
Mass balance and total recovery of [C-14]-radioactivity in urine and feces.
Time frame: From drug administration up to Day 21.
Part A
Area under the concentration-time curve of Carbon-14-labeled BI 1839100 after intravenous administration and BI 1839100 after oral administration, extrapolated to infinity (AUC0-∞).
Time frame: From drug administration up to Day 21.
Part B
4 secondary outcomes
Maximum measured concentration of BI 1839100 and Carbon-14-labeled BI 1839100 in plasma (Cmax).
Time frame: Two hours before drug administration up to Day 21.
Area under the concentration-time curve of BI 1839100 and Carbon-14-labeled BI 1839100 from 0 to the last quantifiable time point (AUC0-tz).
Time frame: Two hours before drug administration up to Day 21.
Area under the concentration-time curve of Carbon-14-labeled BI 1839100 in plasma after intravenous administration and BI 1839100 after oral administration, from 0 to the last quantifiable time point (AUC0-tz).
Time frame: Two hours before drug administration up to 72 hours (Day 4).
Maximum measured concentration of Carbon-14-labeled BI 1839100 in plasma after intravenous administration and BI 1839100 after oral administration (Cmax).
Time frame: Two hours before drug administration up to 72 hours (Day 4).
Results and safety
The study was stopped early (reason given: Company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- 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 BI 1839100 (C-14) formulation 1, BI 1839100 and BI 1839100 (C-14) formulation 2 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 8 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: stopped early, as of the sponsor's last update on 23 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 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 was stopped early (reason given: Company decision). Results are not available in the source record.
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?
Mass balance and total recovery of [C-14]-radioactivity in urine and feces. (time frame: From drug administration up to Day 21.). The study lists 2 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 Sep 2025.