A Study in Healthy Men to Test How Well Different Doses of BI 3731579 Are Tolerated

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Matching placebo to BI 3731579; Drug: BI 3731579

Study type: Interventional

Funder types: Industry

Identifiers

NCT06429137

1519-0001

2023-510318-25-00 (Registry Identifier)

U1111-1304-0523 (Registry Identifier)

Details and patient eligibility

About

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.

Enrollment: 63 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. 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
2. Age of 18 to 45 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
4. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. 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: Single Blind

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63 participants in 9 patient groups, including a placebo group

BI 3731579 dose group 1

Experimental group

Treatment:

Drug: BI 3731579

BI 3731579 dose group 2

Experimental group

Treatment:

Drug: BI 3731579

BI 3731579 dose group 3

Experimental group

Treatment:

Drug: BI 3731579

BI 3731579 dose group 4

Experimental group

Treatment:

Drug: BI 3731579

BI 3731579 dose group 5

Experimental group

Treatment:

Drug: BI 3731579

BI 3731579 dose group 6

Experimental group

Treatment:

Drug: BI 3731579

BI 3731579 dose group 7

Experimental group

Treatment:

Drug: BI 3731579

BI 3731579 dose group 8

Experimental group

Treatment:

Drug: BI 3731579

Placebo

Placebo Comparator group

Treatment:

Drug: Matching placebo to BI 3731579