A Study in Healthy People to Test How Itraconazole Influences the Amount of BI 3031185 in the Blood
- Registration Number
- NCT07211425
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics of a single dose of BI 3031185 following oral administration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 14
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)), and 12-lead electrocardiogram (ECG)
- 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, Pulse rate (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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BI 1584862 (R), then BI 1584862 + itraconazole (T) BI 3031185 R=Reference treatment (Period 1) T=Test treatment (Period 2) BI 1584862 (R), then BI 1584862 + itraconazole (T) Itraconazole R=Reference treatment (Period 1) T=Test treatment (Period 2)
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve of BI 3031185 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) Up to Day 13 Maximum measured concentration of BI 3031185 in plasma (Cmax) Up to Day 13
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve of BI 3031185 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) Up to Day 13
Trial Locations
- Locations (1)
Humanpharmakologisches Zentrum Biberach
🇩🇪Biberach, Germany
Humanpharmakologisches Zentrum Biberach🇩🇪Biberach, Germany