HealthyPhase 1NCT06716190

A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People

A Phase 1 study testing Mid-dose bid BI 3731579, Midazolam and Low-dose bid BI 3731579 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Mid-dose bid BI 3731579, Midazolam and Low-dose bid BI 3731579
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteBelgium
Study dates: 18 Dec 2024to 23 Jun 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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers 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), respiratory rate (RR) and temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 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 ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Who cannot join

Any finding in the medical examination (including BP, PR, RR, temperature 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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or resting pulse rate outside the range of 45 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.

Belgium1 site

SGS Life Science Services - Clinical Research
Edegem, 2650

Other trials in Belgium

About this study

Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3731579 in Healthy Volunteers (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Conditions: Healthy
Being tested: Mid-dose bid BI 3731579, Placebo-matching BI 3731579, Midazolam, Low-dose bid BI 3731579, High-dose bid BI 3731579

What participants receive

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

Mid-dose bid BI 3731579Drug
Day 2 and Day 17: a single mid dose of BI 3731579, with 240 mL of water. Day 4 to Day 16: a double daily mid dose (bid) of BI 3731579 each day, with 240 mL of water.
Placebo-matching BI 3731579Drug
Placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water.
MidazolamDrug
Day 1 and Day 17: 75 micrograms (μg) of Midazolam for injection, orally, with 240 mL of water, as a single dose.
Low-dose bid BI 3731579Drug
Day 2 and Day 17: single low dose of BI 3731579 with 240 milliliters (mL) of water. Day 4 to Day 16: a double daily low dose (bid) of BI 3731579 each day, with 240 mL of water.
High-dose bid BI 3731579Drug
Day 2 and Day 17: single high dose of BI 3731579, with 240 mL of water. Day 4 to Day 16: a double daily high dose (bid) of BI 3731579 each day, with 240 mL of water.

Study groups in NCT06716190
Study group	Role	What they receive
Low-dose bid BI 3731579 + midazolam	Experimental	Healthy subjects took, orally, with 240 milliliters (mL) of water, a single low-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily low-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579. Receives: Drug: Midazolam; Drug: Low-dose bid BI 3731579
Mid-dose bid BI 3731579 + midazolam	Experimental	Healthy subjects took, orally, with 240 milliliters (mL) of water, a single mid-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily mid-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579. Receives: Drug: Mid-dose bid BI 3731579; Drug: Midazolam
High-dose bid BI 3731579 + midazolam	Experimental	Healthy subjects took, orally, with 240 milliliters (mL) of water, a single high-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily high-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579. Receives: Drug: Midazolam; Drug: High-dose bid BI 3731579
Placebo-matching BI 3731579 + midazolam	Placebo comparator	Healthy participants took daily placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water. On Day 1 and on Day 17, they took 75 micrograms (μg) of midazolam for injection, orally, as a daily single dose, with 240 mL of water. On Day 17, midazolam was taken after placebo-matching BI 3731579. Receives: Drug: Placebo-matching BI 3731579; Drug: Midazolam

What is being measured

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

Occurrence of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
The occurrence of any treatment-emergent adverse event (TEAE) assessed as drug-related by the investigator is reported as number of participants. The primary endpoint was analyzed without the microdose of midazolam on Day 1, as defined in the statistical analysis plan.
Measured: From first drug administration on Day 2 until last drug administration on Day 17, plus residual effect period (REP) for each intervention. Up to 19 days.

Secondary outcomes (2)

Area Under the Concentration-time Curve of BI 3731579 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Area under the concentration-time curve of BI 3731579 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after its last dose is reported.
Timeframe: 0.5 hours before first BI 3731579 administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 359.75, 360.25, 360.5, 361, 361.5, 362, 364, 365, 367, 369, 371, 372, 384, and 408 thereafter.
Measured: Up to 408 hours. Detailed timeframe in the description.
Maximum Measured Concentration of BI 3731579 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
Maximum measured concentration of BI 3731579 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after its last dose is reported.
Timeframe: 0.5 hours before first BI 3731579 administration and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 359.75, 360.25, 360.5, 361, 361.5, 362, 364, 365, 367, 369, 371, 372, 384, and 408 thereafter.
Measured: Up to 408 hours. Detailed timeframe in the description.

Timeline

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

18 Dec 202423 Jun 2025

First posted4 Dec 2024
Study start18 Dec 2024
Primary completion19 May 2025
Study completion23 Jun 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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06716190
Sponsor's protocol ID: 1519-0002
Other IDs: 2024-517209-95-00, U1111-1313-5393
Status last verified: Jun 2026
First submitted: 29 Nov 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?

See locations

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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: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3731579 in Healthy Volunteers (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
ClinicalTrials.gov ID: NCT06716190
Acronym / sponsor ID: 1519-0002
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 30 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 18 Dec 2024 (actual)
Primary completion: 19 May 2025 (actual)
Study completion: 23 Jun 2025 (actual)
First posted: 4 Dec 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Low-dose bid BI 3731579 + midazolam	Experimental	Drug: Midazolam, Drug: Low-dose bid BI 3731579Healthy subjects took, orally, with 240 milliliters (mL) of water, a single low-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily low-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
Mid-dose bid BI 3731579 + midazolam	Experimental	Drug: Mid-dose bid BI 3731579, Drug: MidazolamHealthy subjects took, orally, with 240 milliliters (mL) of water, a single mid-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily mid-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
High-dose bid BI 3731579 + midazolam	Experimental	Drug: Midazolam, Drug: High-dose bid BI 3731579Healthy subjects took, orally, with 240 milliliters (mL) of water, a single high-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily high-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
Placebo-matching BI 3731579 + midazolam	Placebo comparator	Drug: Placebo-matching BI 3731579, Drug: MidazolamHealthy participants took daily placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water. On Day 1 and on Day 17, they took 75 micrograms (μg) of midazolam for injection, orally, as a daily single dose, with 240 mL of water. On Day 17, midazolam was taken after placebo-matching BI 3731579.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy volunteers 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), respiratory rate (RR) and temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 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 ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Key exclusion criteria (4 listed)

Any finding in the medical examination (including BP, PR, RR, temperature 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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or resting pulse rate outside the range of 45 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
Mid-dose bid BI 3731579Day 2 and Day 17: a single mid dose of BI 3731579, with 240 mL of water. Day 4 to Day 16: a double daily mid dose (bid) of BI 3731579 each day, with 240 mL of water.	Drug	Mid-dose bid BI 3731579 + midazolam
Placebo-matching BI 3731579Placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water.	Drug	Placebo-matching BI 3731579 + midazolam
MidazolamDay 1 and Day 17: 75 micrograms (μg) of Midazolam for injection, orally, with 240 mL of water, as a single dose.	Drug	High-dose bid BI 3731579 + midazolam, Low-dose bid BI 3731579 + midazolam, Mid-dose bid BI 3731579 + midazolam, Placebo-matching BI 3731579 + midazolam
Low-dose bid BI 3731579Day 2 and Day 17: single low dose of BI 3731579 with 240 milliliters (mL) of water. Day 4 to Day 16: a double daily low dose (bid) of BI 3731579 each day, with 240 mL of water.	Drug	Low-dose bid BI 3731579 + midazolam
High-dose bid BI 3731579Day 2 and Day 17: single high dose of BI 3731579, with 240 mL of water. Day 4 to Day 16: a double daily high dose (bid) of BI 3731579 each day, with 240 mL of water.	Drug	High-dose bid BI 3731579 + midazolam

Primary outcome

Occurrence of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
Time frame: From first drug administration on Day 2 until last drug administration on Day 17, plus residual effect period (REP) for each intervention. Up to 19 days.
The occurrence of any treatment-emergent adverse event (TEAE) assessed as drug-related by the investigator is reported as number of participants. The primary endpoint was analyzed without the microdose of midazolam on Day 1, as defined in the statistical analysis plan.

2 secondary outcomes

Area Under the Concentration-time Curve of BI 3731579 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)
Time frame: Up to 408 hours. Detailed timeframe in the description.
Maximum Measured Concentration of BI 3731579 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)
Time frame: Up to 408 hours. Detailed timeframe in the description.

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-matching BI 3731579 + Midazolam	6	6
Low-dose Bid BI 3731579 + Midazolam	8	8
Mid-dose Bid BI 3731579 + Midazolam	8	8
High-dose Bid BI 3731579 + Midazolam	8	8

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

Time frame: From first drug administration on Day 2 until last drug administration on Day 17, plus residual effect period (REP) for each intervention. Up to 19 days.. Count of participants. Unit: Participants

Measure	Placebo-matching BI 3731579 n = 6	Low-dose Bid BI 3731579 n = 8	Mid-dose Bid BI 3731579 n = 8	High-dose Bid BI 3731579 n = 8
Value	0	4	0	1

Population analysed: Treated set (TS) - all participants who were treated with at least one dose of the trial drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event reporting and all cause-mortality - Midazolam: From initial midazolam administration until first administration of BI 3731579. Up to 1 day. Adverse event reporting - Placebo and BI 3731579 dose groups: From first drug administration to last drug administration for each intervention, plus REP. Up to 19 days. All-cause mortality: From first drug administration to individual study visit for each intervention. Up to 27 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Midazolam	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30
Placebo-matching BI 3731579	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Low-dose Bid BI 3731579	0 of 8 (0%)	8 of 8 (100%)	0 of 8
Mid-dose Bid BI 3731579	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
High-dose Bid BI 3731579	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8

Limitations and caveats (from the sponsor): This trial was stopped after the high-dose group. No participants enrolled for the last dose group.

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 Mid-dose bid BI 3731579, Midazolam and Low-dose bid BI 3731579 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

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: stopped early, 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 Belgium. 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 Assessed as Drug-related by the Investigator (time frame: From first drug administration on Day 2 until last drug administration on Day 17, plus residual effect period (REP) for each intervention. Up to 19 days.). 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 NCT06716190.

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.