HealthyPhase 1NCT07250048
A Study in Healthy Men to Find Out How Different Doses of BI 3009947 Are Tolerated and How Different Formulations or Food Influence How BI 3009947 is Taken up Into the Blood
A Phase 1 study testing BI 3009947 (Formulation A) and BI 3009947 (Formulation B) in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
Single-rising dose (SRD) part: The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3009947 in healthy participants following oral administration of single rising doses. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 3009947 (Formulation A) and BI 3009947 (Formulation B)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 21 Nov 2025to 2 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 45 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 45 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
- Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (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 50 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. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
- Further exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3009947 Administered Orally to Healthy Male Trial Participants, and a Randomised, Open-label, Single-dose, Three-way Cross-over Relative Bioavailability Comparison of Two Different Formulations for Oral Administration of BI 3009947 and the Effect of Food on One of These Formulations in Healthy Male Trial Participants
Single-rising dose (SRD) part:
The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3009947 in healthy participants following oral administration of single rising doses.
Bioavailability (BA) part:
The main objective of the BA part is to investigate the relative bioavailability of two different BI 3009947 formulations (Formulation A and B) and to assess the influence of food on the relative bioavailability of Formulation A or B.
- Conditions
- Healthy
- Being tested
- BI 3009947 (Formulation A), BI 3009947 (Formulation B), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3009947 (Formulation A)Drug
BI 3009947 (Formulation A)
BI 3009947 (Formulation B)Drug
BI 3009947 (Formulation B)
PlaceboDrug
Placebo matching BI 3009947 (Formulation A)
| Study group | Role | What they receive |
|---|---|---|
| SRD part: BI 3009947 Dose group 1 | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 2 | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 3 | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 3fed | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 4 | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 4fed | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 5 | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 5fed | Placebo comparator | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 6 | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 6fed | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 7 | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 7fed | Experimental | Not described Receives: Drug: BI 3009947 (Formulation A) |
| SRD part: Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BA part: Treatment sequence R-T1-T2 | Experimental | Reference treatment R and test treatments T1 and T2. Receives: Drug: BI 3009947 (Formulation A); Drug: BI 3009947 (Formulation B) |
| BA part: Treatment sequence T1-R-T2 | Experimental | Reference treatment R and test treatments T1 and T2. Receives: Drug: BI 3009947 (Formulation A); Drug: BI 3009947 (Formulation B) |
| BA part: Treatment sequence T2-R-T1 | Experimental | Reference treatment R and test treatments T1 and T2. Receives: Drug: BI 3009947 (Formulation A); Drug: BI 3009947 (Formulation B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
This is expressed as the percentage of subjects treated with investigational drug who experience such an event.
Measured: up to Day 14
BA part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)
Measured: up to Day 3
BA part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours)
Measured: up to Day 3
BA part: Cmax (maximum measured concentration of BI 3009947 in plasma)
Measured: up to Day 3
BA part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)
Measured: up to Day 3
Secondary outcomes (6)
SRD part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)
Measured: up to Day 3
SRD part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours)
Measured: up to Day 3
SRD part: Cmax (maximum measured concentration of BI 3009947 in plasma)
Measured: up to Day 3
SRD part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)
Measured: up to Day 3
BA part: AUC0-∞ (area under the concentration-time curve of BI 3009947 in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to Day 3
BA part: AUC0-∞ (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start21 Nov 2025
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Why it stopped: Sponsor 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
- Randomised
- Intervention model
- Crossover
- Model description
- SRD part: placebo-controlled BA part: three-way crossover trial with 3 treatment periods to compare the relative bioavailability of reference treatment R and test treatments T1 and T2
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT07250048
- Sponsor's protocol ID
- 1533-0001
- Other IDs
- 2025-521095-66-00, U1111-1318-3257, 2025
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 1 Apr 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3009947 Administered Orally to Healthy Male Trial Participants, and a Randomised, Open-label, Single-dose, Three-way Cross-over Relative Bioavailability Comparison of Two Different Formulations for Oral Administration of BI 3009947 and the Effect of Food on One of These Formulations in Healthy Male Trial Participants
- ClinicalTrials.gov ID
- NCT07250048
- Acronym / sponsor ID
- 1533-0001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 26 Nov 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.
Single-rising dose (SRD) part:
The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3009947 in healthy participants following oral administration of single rising doses.
Bioavailability (BA) part:
The main objective of the BA part is to investigate the relative bioavailability of two different BI 3009947 formulations (Formulation A and B) and to assess the influence of food on the relative bioavailability of Formulation A or B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 16
- Model description
- SRD part: placebo-controlled BA part: three-way crossover trial with 3 treatment periods to compare the relative bioavailability of reference treatment R and test treatments T1 and T2
| Arm | Type | Receives |
|---|---|---|
| SRD part: BI 3009947 Dose group 1 | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 2 | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 3 | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 3fed | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 4 | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 4fed | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 5 | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 5fed | Placebo comparator | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 6 | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 6fed | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 7 | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: BI 3009947 Dose group 7fed | Experimental | Drug: BI 3009947 (Formulation A) |
| SRD part: Placebo | Placebo comparator | Drug: Placebo |
| BA part: Treatment sequence R-T1-T2 | Experimental | Drug: BI 3009947 (Formulation A), Drug: BI 3009947 (Formulation B)Reference treatment R and test treatments T1 and T2. |
| BA part: Treatment sequence T1-R-T2 | Experimental | Drug: BI 3009947 (Formulation A), Drug: BI 3009947 (Formulation B)Reference treatment R and test treatments T1 and T2. |
| BA part: Treatment sequence T2-R-T1 | Experimental | Drug: BI 3009947 (Formulation A), Drug: BI 3009947 (Formulation B)Reference treatment R and test treatments T1 and T2. |
Who may qualify
- Ages
- 18 to 45 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 45 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
- Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
Key exclusion criteria (5 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 50 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. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
- 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 3009947 (Formulation A)BI 3009947 (Formulation A) | Drug | BA part: Treatment sequence R-T1-T2, BA part: Treatment sequence T1-R-T2, BA part: Treatment sequence T2-R-T1, SRD part: BI 3009947 Dose group 1, SRD part: BI 3009947 Dose group 2, SRD part: BI 3009947 Dose group 3, SRD part: BI 3009947 Dose group 3fed, SRD part: BI 3009947 Dose group 4, SRD part: BI 3009947 Dose group 4fed, SRD part: BI 3009947 Dose group 5, SRD part: BI 3009947 Dose group 5fed, SRD part: BI 3009947 Dose group 6, SRD part: BI 3009947 Dose group 6fed, SRD part: BI 3009947 Dose group 7, SRD part: BI 3009947 Dose group 7fed |
| BI 3009947 (Formulation B)BI 3009947 (Formulation B) | Drug | BA part: Treatment sequence R-T1-T2, BA part: Treatment sequence T1-R-T2, BA part: Treatment sequence T2-R-T1 |
| PlaceboPlacebo matching BI 3009947 (Formulation A) | Drug | SRD part: Placebo |
Primary outcome
SRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: up to Day 14
This is expressed as the percentage of subjects treated with investigational drug who experience such an event.
BA part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)
Time frame: up to Day 3
BA part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours)
Time frame: up to Day 3
BA part: Cmax (maximum measured concentration of BI 3009947 in plasma)
Time frame: up to Day 3
BA part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)
Time frame: up to Day 3
6 secondary outcomes
SRD part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)
Time frame: up to Day 3
SRD part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours)
Time frame: up to Day 3
SRD part: Cmax (maximum measured concentration of BI 3009947 in plasma)
Time frame: up to Day 3
SRD part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)
Time frame: up to Day 3
BA part: AUC0-∞ (area under the concentration-time curve of BI 3009947 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to Day 3
BA part: AUC0-∞ (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to Day 3
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 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 3009947 (Formulation A) and BI 3009947 (Formulation B) in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
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 5 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 1 Apr 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 Germany. 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. Some participants in this study may receive a placebo. 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: Sponsor 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?
SRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator (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 1 Apr 2026.