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

NCT06716190 | Terminated Phase 1

• 3 other identifiers: 1519-00022024-517209-95-00U1111-1313-5393
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

  up to Day 27.

Secondary Outcomes (2)

• 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.

Study Arms (5)

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

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

Placebo matching BI 3731579 DRUG

Placebo matching BI 3731579

MRD: Placebo matching BI 3731579

Midazolam DRUG

Midazolam

MRD: BI 3731579 dose group 1; MRD: BI 3731579 dose group 2; MRD: BI 3731579 dose group 3; MRD: BI 3731579 dose group 4; MRD: Placebo matching BI 3731579

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

• Related Info

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: December 18, 2024
• Primary Completion: May 19, 2025
• Study Completion: June 5, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)