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Status:

ACTIVE_NOT_RECRUITING

A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Healthy

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

Brief Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female subjects following administration of single rising doses a...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Healthy male or female (of non-child-bearing potential) 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), respiratory rate (RR), temperature (TEMP)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
  • Age of 18 to 65 years (inclusive)
  • Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive)
  • Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply
  • Exclusion Criteria:
  • Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
  • Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm).
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.
  • Further exclusion criteria apply.

Exclusion

    Key Trial Info

    Start Date :

    September 12 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 6 2026

    Estimated Enrollment :

    56 Patients enrolled

    Trial Details

    Trial ID

    NCT06575400

    Start Date

    September 12 2024

    End Date

    March 6 2026

    Last Update

    July 28 2025

    Active Locations (1)

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    SGS Life Science Services - Clinical Research

    Edegem, Belgium, 2650