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

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Midazolam; Drug: BI 3731579; Drug: Placebo matching BI 3731579

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • SGS Life Science Services - Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

1. 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
2. Age of 18 to 55 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
4. 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

1. Any finding in the medical examination (including BP, PR, RR, temperature or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. 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)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRD: BI 3731579 dose group 1; MRD= Multiple rising doses	Drug: Midazolam; Midazolam; Drug: BI 3731579; BI 3731579
Experimental: MRD: BI 3731579 dose group 2	Drug: Midazolam; Midazolam; Drug: BI 3731579; BI 3731579
Experimental: MRD: BI 3731579 dose group 3	Drug: Midazolam; Midazolam; Drug: BI 3731579; BI 3731579
Experimental: MRD: BI 3731579 dose group 4	Drug: Midazolam; Midazolam; Drug: BI 3731579; BI 3731579
Placebo Comparator: MRD: Placebo matching BI 3731579	Drug: Midazolam; Midazolam; Drug: Placebo matching BI 3731579; Placebo matching BI 3731579

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)	up to Day 19.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Actual): May 19, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Benzodiazepines; Midazolam
• Other Study ID Numbers: 1519-0002; 2024-517209-95-00 (Registry Identifier: CTIS (EU)); U1111-1313-5393 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No