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

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-08

Study Completion Date

2025-05-27

Brief Summary

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

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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

SINGLE

Participants

Study Groups

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BI 3731579 dose group 1

Group Type EXPERIMENTAL

BI 3731579

Intervention Type DRUG

BI 3731579

BI 3731579 dose group 2

Group Type EXPERIMENTAL

BI 3731579

Intervention Type DRUG

BI 3731579

BI 3731579 dose group 3

Group Type EXPERIMENTAL

BI 3731579

Intervention Type DRUG

BI 3731579

BI 3731579 dose group 4

Group Type EXPERIMENTAL

BI 3731579

Intervention Type DRUG

BI 3731579

BI 3731579 dose group 5

Group Type EXPERIMENTAL

BI 3731579

Intervention Type DRUG

BI 3731579

BI 3731579 dose group 6

Group Type EXPERIMENTAL

BI 3731579

Intervention Type DRUG

BI 3731579

BI 3731579 dose group 7

Group Type EXPERIMENTAL

BI 3731579

Intervention Type DRUG

BI 3731579

BI 3731579 dose group 8

Group Type EXPERIMENTAL

BI 3731579

Intervention Type DRUG

BI 3731579

Placebo

Group Type PLACEBO_COMPARATOR

Matching placebo to BI 3731579

Intervention Type DRUG

Matching placebo to BI 3731579

Interventions

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BI 3731579

Intervention Type DRUG

Matching placebo to BI 3731579

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes