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Completed

NCT Number: NCT06861829

A Study in Healthy Men to Test Whether Food Influences the Amount of BI 3731579 in the Blood

This trial investigates whether food influences the amount of BI 3731579 in the blood.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

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

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 18.5 to 29.9 kg/m² (inclusive)
  • 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, 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 3731579

Drug

BI 3731579

Primary outcomes

  1. Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

    Time frame: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration

    Area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.

  2. Maximum Measured Concentration of BI 3731579 in Plasma (Cmax)

    Time frame: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration

    Maximum measured concentration of BI 3731579 in plasma (Cmax) is presented.

Secondary outcomes

  1. Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Time frame: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration

    Area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

The Effect of Food on the Single-dose Pharmacokinetics of BI 3731579 Administered Orally in Healthy Male Subjects (an Open Label, Two-period, Two-sequence Crossover Trial)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Aug 11, 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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