A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: BI 3031185; Drug: Midazolam; Drug: Placebo

• Registration Number: NCT06916702
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-31
• Study Start: 2025-04-07
• Study First Posted: 2025-04-08
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-08-27
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Healthy male subjects 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)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 50 years (inclusive)
• Body Mass Index (BMI) of 20.0 to 29.9 kg/m (inclusive) and body weight of at least 60 kg
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria

• Any finding in the medical examination (including BP, Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement at screening of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam)	BI 3031185	-
Dose group 3 (receiving BI 3031185 or Placebo, plus midazolam)	BI 3031185	-
Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam)	Midazolam	-
Dose group 3 (receiving BI 3031185 or Placebo, plus midazolam)	Midazolam	-
Dose group 3 (receiving BI 3031185 or Placebo, plus midazolam)	Placebo	-
Dose group 4 (receiving BI 3031185 or Placebo, plus midazolam)	BI 3031185	-
Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam)	Placebo	-
Dose group 2 (receiving BI 3031185 or Placebo, plus midazolam)	BI 3031185	-
Dose group 2 (receiving BI 3031185 or Placebo, plus midazolam)	Placebo	-
Dose group 5 (receiving BI 3031185 or Placebo, plus midazolam)	Midazolam	-
Dose group 5 (receiving BI 3031185 or Placebo, plus midazolam)	Placebo	-
Dose group 2 (receiving BI 3031185 or Placebo, plus midazolam)	Midazolam	-
Dose group 4 (receiving BI 3031185 or Placebo, plus midazolam)	Midazolam	-
Dose group 4 (receiving BI 3031185 or Placebo, plus midazolam)	Placebo	-
Dose group 5 (receiving BI 3031185 or Placebo, plus midazolam)	BI 3031185	-
Dose group 6 (receiving BI 3031185 or Placebo, plus midazolam)	BI 3031185	-
Dose group 6 (receiving BI 3031185 or Placebo, plus midazolam)	Midazolam	-
Dose group 6 (receiving BI 3031185 or Placebo, plus midazolam)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator	Up to Day 54

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 3031185 in plasma at steady state over a uniform dosing interval τ ((AUC) τ,ss )	Up to Day 42
Maximum measured concentration of BI 3031185 in plasma at steady state over a uniform dosing interval τ (Cmax,ss)	Up to Day 42

Trial Locations

Locations (1)

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany