A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body
- Conditions
- Healthy
- Registration Number
- NCT06494761
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria:<br><br> - Healthy male subjects according to the assessment of the investigator, as based on a<br> complete medical history including a physical examination, vital signs (blood<br> pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical<br> laboratory tests<br><br> - Age of 18 to 55 years (inclusive)<br><br> - Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)<br><br> - Signed and dated written informed consent<br><br>Exclusion Criteria:<br><br> - Any finding in the medical examination (including BP, PR or ECG) deviating from<br> normal and assessed as clinically relevant by the investigator<br><br> - Repeated measurement of systolic blood pressure outside the range of 90 to 140<br> millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to<br> 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)<br><br> - Any laboratory value outside the reference range that the investigator considers to<br> be of clinical relevance<br><br> - Any evidence of a concomitant disease assessed as clinically relevant by the<br> investigator Further exclusion criteria apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-8);Maximum measured concentration of the analyte in plasma (Cmax)
- Secondary Outcome Measures
Name Time Method 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)