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

Safety, Tolerability, and Pharmacokinetics of Multiple Rising Oral Doses of BI 3031185 in Healthy Male and Female Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Part A: 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.

Part B: The main objectives of Part B of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3031185 in healthy male subjects and female subjects of non-childbearing potential following oral administration of multiple doses of BI 3031185.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Midazolam; Drug: BI 3031185; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité Research Organisation GmbH
    • Contact: Boehringer Ingelheim; Phone Number: 08007234742; Email: deutschland@bitrialsupport.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Part A: 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 Part B: Healthy male and female (women of non-childbearing potential) subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Part A: Age of 18 to 50 years (inclusive) Part B: Age of 18 to 55 years (inclusive)
• Part A: 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

• Part B: For female trial participants: Female trial participants who meet any of the following criteria (women of non-childbearing potential):

  • Permanently sterilised (including hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
  • Postmenopausal, defined as no menses for at least 1 year without an alternative medical cause. In questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L at screening is confirmatory
• Further inclusion criteria apply

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 Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam)	Drug: Midazolam; Midazolam; Drug: BI 3031185; BI 3031185; Drug: Placebo; Placebo matching BI 3031185
Experimental: Dose group 2 (receiving BI 3031185 or Placebo, plus midazolam)	Drug: Midazolam; Midazolam; Drug: BI 3031185; BI 3031185; Drug: Placebo; Placebo matching BI 3031185
Experimental: Dose group 3 (receiving BI 3031185 or Placebo, plus midazolam)	Drug: Midazolam; Midazolam; Drug: BI 3031185; BI 3031185; Drug: Placebo; Placebo matching BI 3031185
Experimental: Dose group 4 (receiving BI 3031185 or Placebo, plus midazolam)	Drug: Midazolam; Midazolam; Drug: BI 3031185; BI 3031185; Drug: Placebo; Placebo matching BI 3031185
Experimental: Dose group 5 (receiving BI 3031185 or Placebo, plus midazolam)	Drug: Midazolam; Midazolam; Drug: BI 3031185; BI 3031185; Drug: Placebo; Placebo matching BI 3031185
Experimental: Dose group 6 (receiving BI 3031185 or Placebo, plus midazolam)	Drug: Midazolam; Midazolam; Drug: BI 3031185; BI 3031185; Drug: Placebo; Placebo matching BI 3031185
Experimental: Part B (receiving BI 3031185 or placebo)	Drug: BI 3031185; BI 3031185; Drug: Placebo; Placebo matching BI 3031185

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 54

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): October 7, 2026
• Study Completion (Estimated): October 7, 2026

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 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: 1516-0002; 2024-516921-29-00 (Registry Identifier: CTIS (EU)); U1111-1311-3555 (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