A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 764198 in the Blood (NCT07308652) | Clinical Trial Compass
CompletedPhase 1
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 764198 in the Blood
Germany14 participantsStarted 2026-02-09
Plain-language summary
The purpose of this study is to find out whether a medicine called itraconazole changes the amount of another medicine called BI 764198 in the blood. Some people may take more than 1 medicine at a time. Therefore, it is important to understand how medicines influence each other. This study will help us learn more about how BI 764198 works.
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
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 trial participant 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 / m\^2 (inclusive)
* 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, 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 was a Phase 1 drug interaction study testing how itraconazole affects BI 764198 blood levels — what does it mean for me if BI 764198 is affected by common antifungal medications, and could that be relevant to any treatments I'm already taking?
2Since this study only enrolled healthy men and is now completed, is the safety and drug interaction data from it publicly available, and how might those findings shape whether BI 764198 moves forward into studies for actual patients?
3The trial measured how much BI 764198 stays in the blood when combined with itraconazole — if those levels turned out to be significantly higher or lower, what would that tell us about how carefully this drug's dosing would need to be managed in real patients?
4Because this was a Phase 1 study in healthy volunteers rather than patients with a specific condition, what would still need to be proven in later-phase trials before BI 764198 could be considered a realistic treatment option for someone in my situation?
5Are there other trials involving BI 764198 that are currently recruiting patients, and would the drug interaction findings from this completed study affect whether I might be a candidate for those?
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 BI 764198 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Timeframe: Up to Day 5 (Period 1 and Period 2)
2
Maximum measured concentration of BI 764198 in plasma (Cmax)