HealthyPhase 1NCT06861829

A Study in Healthy Men to Test Whether Food Influences the Amount of BI 3731579 in the Blood

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.

Official record

Search all trials

Trial summary

This trial investigates whether food influences the amount of BI 3731579 in the blood. Read more about this study

Who is it for?: Ages 18 to 50 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?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteGermany
Study dates: 19 Mar 2025to 23 Apr 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 50 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 50 years (inclusive)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m² (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 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.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: The Effect of Food on the Single-dose Pharmacokinetics of BI 3731579 Administered Orally in Healthy Male Subjects (an Open Label, Two-period, Two-sequence Crossover Trial)

This trial investigates whether food influences the amount of BI 3731579 in the blood.

Conditions: Healthy
Being tested: BI 3731579

What participants receive

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

BI 3731579Drug
BI 3731579

Study groups in NCT06861829
Study group	Role	What they receive
BI 3731579 fasted - fed (R-T)	Experimental	Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations. Receives: Drug: BI 3731579
BI 3731579 fed - fasted (T-R)	Experimental	Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations. Receives: Drug: BI 3731579

What is being measured

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

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 (AUC0-tz) is presented.
Measured: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration
Maximum Measured Concentration of BI 3731579 in Plasma (Cmax)
Maximum measured concentration of BI 3731579 in plasma (Cmax) is presented.
Measured: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration

Secondary outcomes (1)

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 (AUC0-∞) is presented.
Measured: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration

Timeline

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

19 Mar 202523 Apr 2025

First posted6 Mar 2025
Study start19 Mar 2025
Primary completion17 Apr 2025
Study completion23 Apr 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: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06861829
Sponsor's protocol ID: 1519-0004
Other IDs: 2024-517895-39-00, U1111-1314-3696
Status last verified: Jun 2026
First submitted: 3 Mar 2025
Last updated: 11 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Food on the Single-dose Pharmacokinetics of BI 3731579 Administered Orally in Healthy Male Subjects (an Open Label, Two-period, Two-sequence Crossover Trial)
ClinicalTrials.gov ID: NCT06861829
Acronym / sponsor ID: 1519-0004
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 19 Mar 2025 (actual)
Primary completion: 17 Apr 2025 (actual)
Study completion: 23 Apr 2025 (actual)
First posted: 6 Mar 2025 (actual)
Results: Posted 11 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial investigates whether food influences the amount of BI 3731579 in the blood.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BI 3731579 fasted - fed (R-T)	Experimental	Drug: BI 3731579Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations.
BI 3731579 fed - fasted (T-R)	Experimental	Drug: BI 3731579Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations.

Who may qualify

Ages: 18 to 50 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 50 years (inclusive)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m² (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 (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
BI 3731579BI 3731579	Drug	BI 3731579 fasted - fed (R-T), BI 3731579 fed - fasted (T-R)

Primary outcome

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)
Time frame: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration
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) is presented.
Maximum Measured Concentration of BI 3731579 in Plasma (Cmax)
Time frame: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration
Maximum measured concentration of BI 3731579 in plasma (Cmax) is presented.

1 secondary outcome

Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration

Results and safety

Results posted to the registry on 11 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
BI 3731579 Fasted - Fed (R-T)	6	6
BI 3731579 Fed - Fasted (T-R)	6	6

Primary outcome: 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)

Time frame: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration. Geometric least squares mean (Standard Error). Unit: hours*nanomoles/Liters (h*nmol/L)

Measure	BI 3731579 Fed (T) n = 12	BI 3731579 Fasted (R) n = 12
Value	15045.02 (NA)	16708.83 (NA)

BI 3731579 Fed (T) vs BI 3731579 Fasted (R): gMean Ratio: 90.04 (90% CI 84.26 to 96.22)

Population analysed: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetics (PK) endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment.

Primary outcome: Maximum Measured Concentration of BI 3731579 in Plasma (Cmax)

Measure	BI 3731579 Fed (T) n = 12	BI 3731579 Fasted (R) n = 12
Value	2115.09 (NA)	2784.23 (NA)

BI 3731579 Fed (T) vs BI 3731579 Fasted (R): gMean Ratio: 75.97 (90% CI 63.96 to 90.23)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For all on-treatment AEs: From first drug administration in this period until 3 days (72 h) thereafter, up to 3 days. All-cause mortality: From first drug administration until end of follow-up period, up to 15 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 3731579 Fasted (R)	0 of 12 (0%)	3 of 12 (25%)	0 of 12
BI 3731579 Fed (T)	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 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

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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 11 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. 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 11 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?

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) (time frame: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration). 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?

On the ClinicalTrials.gov record for NCT06861829.

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 11 Aug 2026.