Skip to main content
OpenTrials
Completed

NCT Number: NCT06429137

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 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 45 years (inclusive)
  • Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
  • 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

  • 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 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)
  • 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

Participants received a single oral dose of BI 3731579 as film-coated tablets, with 240 mL of water following an overnight fast of at least 10 hrs. The doses received were respectively 6 mg (DG 1), 21 mg (DG 2), 60 mg (DG 3), 120 mg (DG 4), 210 mg (DG 5), 360 mg (DG 6), 480 mg (DG 7) and 600 mg (DG 8).

Placebo

Drug

Participants received BI 3731579-matched placebo as film-coated tablets and as a single oral dose, with 240 milliliters (mL) of water following an overnight fast of at least 10 hours (hrs).

Primary outcomes

  1. Occurrence of Any Treatment-emergent Adverse Event (AE) Assessed as Drug-related by the Investigator

    Time frame: From timepoint of drug administration plus the residual effect period, up to 4 days (96 hours) after drug administration.

    The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator is reported.

Secondary outcomes

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

    Time frame: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.

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

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

    Time frame: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.

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

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

    Time frame: Measured within 3 hours prior to drug administration and at 0.25 hours (hrs), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48 and 72 hrs after drug intake.

    Cmax (maximum measured concentration of BI 3731579 in plasma) is reported.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Partially Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3731579 Administered as Tablet to Healthy Male Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 24, 2024
Registry last updated
Aug 10, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.