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

Boehringer Ingelheim

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Midazolam; Drug: Placebo; Drug: BI 3031185

Study type: Interventional

Funder types: Industry

Identifiers

NCT06916702

2024-516921-29-00 (Registry Identifier)

1516-0002

U1111-1311-3555 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 6 patient groups

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

Experimental group

Treatment:

Drug: BI 3031185

Drug: Placebo

Drug: Midazolam

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

Experimental group

Treatment:

Drug: BI 3031185

Drug: Placebo

Drug: Midazolam

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

Experimental group

Treatment:

Drug: BI 3031185

Drug: Placebo

Drug: Midazolam

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

Experimental group

Treatment:

Drug: BI 3031185

Drug: Placebo

Drug: Midazolam

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

Experimental group

Treatment:

Drug: BI 3031185

Drug: Placebo

Drug: Midazolam

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

Experimental group

Treatment:

Drug: BI 3031185

Drug: Placebo

Drug: Midazolam