A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood
The Effect of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Oral Dose of BI 1810631 in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
Sponsor: Boehringer Ingelheim
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration.
Maximum Measured Concentration of Zongertinib in Plasma (Cmax)
Time frame: One hour before administration of zongertinib, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 11, 12, 24, 36, 48, 72, 120, and 168 hours after administration.
Secondary Endpoints
Area Under the Concentration-time Curve of Zongertinib in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Eligibility Criteria
Inclusion Criteria: * Healthy male 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 ICH-GCP and local legislation prior to admission to the trial Exclusion Criteria: * Any finding in the medical examination (including BP, PR or ECG, the neurological examination, or the skin inspection) 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 50 to 90 bpm * Any laboratory value outside the reference range that the investigator considers…
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