A Study in Healthy People to Test How 3 Different Formulations of BI 764198 Are Taken up in the B… (NCT06955754) | Clinical Trial Compass
CompletedPhase 1
A Study in Healthy People to Test How 3 Different Formulations of BI 764198 Are Taken up in the Body and How This is Influenced by Food
Germany16 participantsStarted 2025-05-20
Plain-language summary
This trial aims to investigate the relative bioavailability of three different oral formulations of BI 764198 and how this is influenced by food.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Healthy male or female 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 55 years (inclusive)
* Body Mass Index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
* Signed and dated written informed consent in accordance with the International Council for Harmonisation - 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 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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested three different formulations of BI 764198 in healthy volunteers — if this drug is being considered for my condition, can you explain what these formulation differences mean and how they might affect which version I'd eventually receive?
2Since this was a Phase 1 study focused on how the body absorbs BI 764198 rather than on treating a disease, what do the findings about absorption rates (AUC and Cmax) tell us so far about whether this drug is moving forward in development?
3The trial looked at how food affects the way BI 764198 is absorbed — based on what's been found, would taking this medication with or without food be a consideration in any future treatment plan?
4Because this was a completed Phase 1 study in healthy people, what additional phases of testing would still need to happen before this drug could be considered a real treatment option for someone with my diagnosis?
5Are there already approved or standard treatments I should consider first, given that BI 764198 is still in early-stage research and may be years away from broader clinical use?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Timeframe: up to 4 days
2
Maximum measured concentration of the analyte in plasma (Cmax)