HealthyPhase 1NCT06429137

A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated

A Phase 1 study testing BI 3731579 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects. 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 3731579
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteGermany
Study dates: 8 Jul 2024to 27 May 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 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 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 of Technical Requirements for Pharmaceuticals for Human Use - 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 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (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.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3731579 Administered as Tablet to Healthy Male Subjects

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.

Conditions: Healthy
Being tested: BI 3731579, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 3731579Drug
Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).
PlaceboDrug
Participants received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).

Study groups in NCT06429137
Study group	Role	What they receive
Dose group (DG) 1, 6 mg BI 3731579	Experimental	DG 1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. Receives: Drug: BI 3731579
DG 2, 21 mg BI 3731579	Experimental	DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. Receives: Drug: BI 3731579
DG 3, 60 mg BI 3731579	Experimental	DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. Receives: Drug: BI 3731579
DG 4, 120 mg BI 3731579	Experimental	DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. Receives: Drug: BI 3731579
DG 5, 210 mg BI 3731579	Experimental	DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. Receives: Drug: BI 3731579
DG 6, 360 mg BI 3731579	Experimental	DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. Receives: Drug: BI 3731579
DG 7, 480 mg BI 3731579	Experimental	DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. Receives: Drug: BI 3731579
DG 8, 600 mg BI 3731579	Experimental	DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. Receives: Drug: BI 3731579
Placebo	Placebo comparator	This group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator
The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator is reported.
Measured: From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.

Secondary outcomes (3)

AUC0-tz (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)
AUC0-tz (area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 to the last quantifiable data point) is reported.
Measured: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
AUC0-∞ (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
AUC0-∞ (area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 extrapolated to infinity) is reported.
Measured: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
Cmax (Maximum Measured Concentration of BI 3731579 in Plasma)
Cmax (maximum measured concentration of BI 3731579 in plasma) is reported.
Measured: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 202427 May 2025

First posted24 May 2024
Study start8 Jul 2024
Primary completion19 May 2025
Study completion27 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06429137
Sponsor's protocol ID: 1519-0001
Other IDs: 2023-510318-25-00, U1111-1304-0523, 2023
Status last verified: Jun 2026
First submitted: 21 May 2024
Last updated: 10 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3731579 Administered as Tablet to Healthy Male Subjects
ClinicalTrials.gov ID: NCT06429137
Acronym / sponsor ID: 1519-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 8 Jul 2024 (actual)
Primary completion: 19 May 2025 (actual)
Study completion: 27 May 2025 (actual)
First posted: 24 May 2024 (actual)
Results: Posted 10 Aug 2026

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 of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 9

Arm	Type	Receives
Dose group (DG) 1, 6 mg BI 3731579	Experimental	Drug: BI 3731579DG 1 comprised participants who received a single oral dose of 6 milligrams (mg) BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
DG 2, 21 mg BI 3731579	Experimental	Drug: BI 3731579DG 2 comprised participants who received a single oral dose of 21 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
DG 3, 60 mg BI 3731579	Experimental	Drug: BI 3731579DG 3 comprised participants who received a single oral dose of 60 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
DG 4, 120 mg BI 3731579	Experimental	Drug: BI 3731579DG 4 comprised participants who received a single oral dose of 120 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
DG 5, 210 mg BI 3731579	Experimental	Drug: BI 3731579DG 5 comprised participants who received a single oral dose of 210 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
DG 6, 360 mg BI 3731579	Experimental	Drug: BI 3731579DG 6 comprised participants who received a single oral dose of 360 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
DG 7, 480 mg BI 3731579	Experimental	Drug: BI 3731579DG 7 comprised participants who received a single oral dose of 480 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
DG 8, 600 mg BI 3731579	Experimental	Drug: BI 3731579DG 8 comprised participants who received a single oral dose of 600 mg BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs.
Placebo	Placebo comparator	Drug: PlaceboThis group comprised all participants who received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).

Who may qualify

Ages: 18 to 45 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 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 of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (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 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (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
BI 3731579Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).	Drug	DG 2, 21 mg BI 3731579, DG 3, 60 mg BI 3731579, DG 4, 120 mg BI 3731579, DG 5, 210 mg BI 3731579, DG 6, 360 mg BI 3731579, DG 7, 480 mg BI 3731579, DG 8, 600 mg BI 3731579, Dose group (DG) 1, 6 mg BI 3731579
PlaceboParticipants received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).	Drug	Placebo

Primary outcome

Occurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator
Time frame: From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.
The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator is reported.

3 secondary outcomes

AUC0-tz (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)
Time frame: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
AUC0-∞ (Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Time frame: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.
Cmax (Maximum Measured Concentration of BI 3731579 in Plasma)
Time frame: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.

Results and safety

Results posted to the registry on 10 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	15	15
Dose Group (DG) 1, 6 mg BI 3731579	6	6
DG 2, 21 mg BI 3731579	6	6
DG 3, 60mg BI 3731579	6	6
DG 4, 120mg BI 3731579	6	6
DG 5, 210mg BI 3731579	6	6
DG 6, 360mg BI 3731579	6	6
DG 7, 480mg BI 3731579	6	6
DG 8, 600mg BI 3731579	6	6

Primary outcome: Occurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator

Time frame: From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.. Count of participants. Unit: Participants

Measure	Placebo n = 15	Dose Group (DG) 1, 6 mg BI 3731579 n = 6	DG 2, 21 mg BI 3731579 n = 6	DG 3, 60 mg BI 3731579 n = 6	DG 4, 120 mg BI 3731579 n = 6	DG 5, 210 mg BI 3731579 n = 6	DG 6, 360 mg BI 3731579 n = 6	DG 7, 480 mg BI 3731579 n = 6	DG 8, 600 mg BI 3731579 n = 6
Value	0	0	0	0	0	0	2	0	4

Population analysed: The treated set (TS) included all subjects who were treated with at least 1 dose of trial drug and was used for the safety analyses.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality: From first drug administration until end of study, up to 14 days. Serious and other adverse events: From timepoint of drug administration plus the residual effect period, up to 4 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 15 (0%)	3 of 15 (20%)	0 of 15
Dose Group (DG) 1, 6mg BI 3731579	0 of 6 (0%)	0 of 6 (0%)	0 of 6
DG 2, 21 mg BI 3731579	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
DG 3, 60 mg BI 3731579	0 of 6 (0%)	0 of 6 (0%)	0 of 6
DG 4, 120 mg BI 3731579	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
DG 5, 210mg BI 3731579	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
DG 6, 360mg BI 3731579	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
DG 7, 480mg BI 3731579	0 of 6 (0%)	3 of 6 (50%)	0 of 6
DG 8, 600mg BI 3731579	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 3731579 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 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 10 Aug 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?

Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Occurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator (time frame: From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06429137.

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 10 Aug 2026.