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OpenTrials
Completed

NCT Number: NCT06631430

A Study to Test How Well Different Doses of BI 3810477 Are Tolerated by Healthy Men

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3810477 in healthy male subjects.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

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 60 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 conference on harmonization-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
  • Male subjects who are willing to use condoms to prevent unintended exposure of their partner (both, male and female) from time point of administration of trial medication until completion of 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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate 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
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator
  • Further exclusion criteria apply

Treatment and study plan

BI 3810477

Drug

BI 3810477 formulation A

Placebo

Drug

Placebo

Primary outcomes

  1. Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

    Time frame: Up to Day 85

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 Day 85

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

    Time frame: Up to Day 85

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3810477 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Jun 18, 2025

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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