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OpenTrials
Completed

NCT Number: NCT06984926

A Study to Test How Well Multiple Doses of BI 3810477 Are Tolerated by Healthy Adults

The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 3810477 in healthy male and female trial participants when given as multiple rising doses.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

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 and female participants 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), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
  • Age of 18 to 60 years (inclusive, to be checked at time of signing informed consent).
  • 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.
  • Further inclusion criteria apply.

Exclusion criteria

  • Any finding in the medical examination (including BP, PR, RR, temperature 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

Placebo

Drug

Placebo for BI 3810477

Primary outcomes

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

    Time frame: Up to Day 117

Secondary outcomes

  1. Area under the concentration-time curve of BI 3810477 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)

    Time frame: Up to Day 117

  2. Maximum measured concentration of BI 3810477 in plasma at steady state (Cmax,ss)

    Time frame: Up to Day 117

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2025
Registry last updated
Mar 19, 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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