A Study to Test How BI 1819479 is Taken up and Processed by the Body

Launched by BOEHRINGER INGELHEIM · Jul 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called BI 1819479 to understand how it is absorbed, processed, and eliminated by the body. The study is being done in healthy men to see how the drug moves through the body and how much of it is available after taking it. This is an early-stage (Phase 1) trial, which means it focuses on safety and basic information about the drug rather than testing how well it works for treating any illness.

Men between the ages of 18 and 55 who are generally healthy may be eligible to take part. To join, participants must have a normal health check-up, including blood pressure, heart rate, and lab tests, and they need to have a body weight within a certain range. Those who have any serious health problems, certain surgeries, or irregular bowel movements (for part of the study) would not be able to participate. If you join, you can expect careful health monitoring and tests to track the drug in your body. It’s important to know that the study is not yet recruiting volunteers, so if you’re interested, you’ll need to wait for the trial to open.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male 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)), 12-lead electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities
• • 2. Age of 18 to 55 years (inclusive)
• • 3. Body Mass Index (BMI) of 18.5 to 32.0 kg/m\^2 (inclusive)
• • 4. Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• • 5. Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day), applicable to Part A only
• Exclusion Criteria:
• • 1. Any finding in the medical examination (including vital signs or ECG) deviating from normal and assessed as clinically relevant by the investigator
• • 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mm Hg, or heart rate outside the range of 45 to 90 bpm (beats per minute)
• • 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• • 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• • 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, assessed as clinically relevant by the investigator
• • 6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
• • 7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• • 8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.