The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses. The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM). Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
62
1308.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Number of Participants With Drug Related AEs
Number of participants with drug related adverse events (AEs)
Time frame: From drug administration until end of trial examination, up to 13 days
Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests
Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).
Time frame: From drug administration until end of trial examination, up to 13 days
Maximum Measured Concentration (Cmax )
Maximum measured concentration of the analyte (BI 411034) in plasma
Time frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Time to Maximum Measured Concentration (Tmax)
Time from dosing to maximum measured concentration
Time frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)
Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity
Time frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration
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Low dose solution for oral administration
High dose solution for oral administration
High dose solution for oral administration
Medium dose solution for oral administration
High dose solution for oral administration
Medium dose solution for oral administration
Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)
Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.
Time frame: 2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration