A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men

Launched by BOEHRINGER INGELHEIM · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BI 3031185 to see how well different doses are tolerated by healthy men. The main focus is on understanding the safety of the drug and how it moves through the body. The trial is currently looking for healthy male participants aged between 18 and 50 years, who have a body mass index (BMI) between 20.0 and 29.9 and weigh at least 60 kilograms. Before joining, eligible participants will need to provide written consent after being assessed by the study team to ensure they meet all health criteria.

Participants in this trial can expect to receive varying doses of the medication while being closely monitored for any side effects or health changes. This study is important because it helps researchers find out how safe the drug is for use in future treatments. If you or someone you know fits the eligibility criteria and is interested in contributing to medical research, this trial could be a valuable opportunity.

Gender

MALE

Eligibility criteria

• 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 20.0 to 29.9 kg/m (inclusive) and body weight of at least 60 kg
• • 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, Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
• • Repeated measurement at screening of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 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