A Study to Test How Different Doses of BI 3731579 Are Tol... | NCT06716190

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

NCT06716190

Sponsor

Boehringer Ingelheim

Status

Terminated

Last Update Posted

Mar 17, 2026Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

BI 3731579
Placebo matching BI 3731579
Midazolam

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2024-517209-95-00	Registry Identifier	CTIS (EU)
U1111-1313-5393	Registry Identifier	WHO International Clinical Trials Registry Platform (ICTRP)

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Dec 18, 2024Actual

Primary Completion Date

May 19, 2025Actual

Completion Date

Jun 5, 2025Actual

First Submitted Date

Nov 29, 2024

First Submission Date that Met QC Criteria

Nov 29, 2024

First Posted Date

Dec 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRD: BI 3731579 dose group 1	Experimental	MRD= Multiple rising doses	Drug: BI 3731579 Drug: Midazolam
MRD: BI 3731579 dose group 2	Experimental		Drug: BI 3731579 Drug: Midazolam
MRD: BI 3731579 dose group 3	Experimental		Drug: BI 3731579 Drug: Midazolam
MRD: BI 3731579 dose group 4	Experimental		Drug: BI 3731579 Drug: Midazolam
MRD: Placebo matching BI 3731579	Placebo Comparator		Drug: Placebo matching BI 3731579 Drug: Midazolam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BI 3731579	Drug	BI 3731579	MRD: BI 3731579 dose group 1 MRD: BI 3731579 dose group 2 MRD: BI 3731579 dose group 3 MRD: BI 3731579 dose group 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator		up to Day 27.

Secondary Outcomes

Measure	Description	Time Frame
AUCτ,ss (area under the concentration-time curve of BI 3731579 in plasma at steady state over a uniform dosing interval τ)		up to Day 19.
Cmax,ss (maximum measured concentration of BI 3731579 in plasma at steady state over a uniform dosing interval τ)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

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.

Exclusion criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
SGS Life Science Services - Clinical Research		Edegem		2650	Belgium

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 23, 2026

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided