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Completed

NCT Number: NCT06955754

A Study in Healthy People to Test How 3 Different Formulations of BI 764198 Are Taken up in the Body and How This is Influenced by Food

This trial aims to investigate the relative bioavailability of three different oral formulations of BI 764198 and how this is influenced by food.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach/Riss, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female 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 55 years (inclusive)
  • Body Mass Index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
  • Signed and dated written informed consent in accordance with the International Council for Harmonisation - 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 blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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.

Treatment and study plan

BI 764198, formulation 1

Drug

BI 764198, formulation 1

Other names: Apecotrep

BI 764198, formulation 2

Drug

BI 764198, formulation 2

Other names: Apecotrep

BI 764198, formulation 3

Drug

BI 764198, formulation 3

Other names: Apecotrep

Primary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

    Time frame: up to 4 days

  2. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: up to 4 days

Secondary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: up to 4 days

  2. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point, dose normalized (AUC0-tz, norm)

    Time frame: up to 4 days

  3. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity, dose normalized (AUC0-∞, norm)

    Time frame: up to 4 days

  4. Maximum measured concentration of the analyte in plasma, dose normalised (Cmax, norm)

    Time frame: up to 4 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Relative Bioavailability of Three Different Oral Formulations of BI 764198 Including the Investigation of Food Effect on the Tablet Formulation in Healthy Male and Female Subjects (an Open-label, Randomised, Four-way Crossover Trial)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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