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

NCT ID: NCT06916702

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Outcome assessors may be unblinded upon request, except for Electrocardiogram (ECG) laboratory staff, who shall remain blinded throughout the study.

Study Groups

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Dose group 1 (receiving BI 3031185 or Placebo, plus midazolam)

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

Midazolam

Intervention Type DRUG

Midazolam

Placebo

Intervention Type DRUG

Placebo matching BI 3031185

Dose group 2 (receiving BI 3031185 or Placebo, plus midazolam)

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

Midazolam

Intervention Type DRUG

Midazolam

Placebo

Intervention Type DRUG

Placebo matching BI 3031185

Dose group 3 (receiving BI 3031185 or Placebo, plus midazolam)

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

Midazolam

Intervention Type DRUG

Midazolam

Placebo

Intervention Type DRUG

Placebo matching BI 3031185

Dose group 4 (receiving BI 3031185 or Placebo, plus midazolam)

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

Midazolam

Intervention Type DRUG

Midazolam

Placebo

Intervention Type DRUG

Placebo matching BI 3031185

Dose group 5 (receiving BI 3031185 or Placebo, plus midazolam)

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

Midazolam

Intervention Type DRUG

Midazolam

Placebo

Intervention Type DRUG

Placebo matching BI 3031185

Dose group 6 (receiving BI 3031185 or Placebo, plus midazolam)

Group Type EXPERIMENTAL

BI 3031185

Intervention Type DRUG

BI 3031185

Midazolam

Intervention Type DRUG

Midazolam

Placebo

Intervention Type DRUG

Placebo matching BI 3031185

Interventions

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BI 3031185

BI 3031185

Intervention Type DRUG

Midazolam

Midazolam

Intervention Type DRUG

Placebo

Placebo matching BI 3031185

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Charité Research Organisation GmbH

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Boehringer Ingelheim

Role: CONTACT

[email protected]
1-800-243-0127

Facility Contacts

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Boehringer Ingelheim

Role: primary

[email protected]
08007234742

Related Links

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http://www.mystudywindow.com

Related Info

Other Identifiers

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2024-516921-29-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1311-3555

Identifier Type: REGISTRY

Identifier Source: secondary_id

1516-0002

Identifier Type: -

Identifier Source: org_study_id

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