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: Low-dose bid BI 3731579; Drug: Mid-dose bid BI 3731579; Drug: High-dose bid 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose bid BI 3731579 + midazolam; 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.	Drug: Midazolam; Day 1 and Day 17: 75 micrograms (μg) of Midazolam for injection, orally, with 240 mL of water, as a single dose.; Drug: Low-dose bid BI 3731579; 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.
Experimental: Mid-dose bid BI 3731579 + midazolam; 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.	Drug: Midazolam; Day 1 and Day 17: 75 micrograms (μg) of Midazolam for injection, orally, with 240 mL of water, as a single dose.; Drug: Mid-dose bid BI 3731579; 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.
Experimental: High-dose bid BI 3731579 + midazolam; 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.	Drug: Midazolam; Day 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; 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.
Placebo Comparator: Placebo-matching BI 3731579 + midazolam; 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.	Drug: Midazolam; Day 1 and Day 17: 75 micrograms (μg) of Midazolam for injection, orally, with 240 mL of water, as a single dose.; Drug: Placebo-matching BI 3731579; Placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 408 hours. Detailed timeframe in the description.

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 23, 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): August 10, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 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