The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy male subjects following oral administration of multiple rising doses over 14 days (MRD part). Secondary objectives for the MRD part are the exploration of PK (Pharmacokinetic(s)), including dose proportionality, as well as investigation of linearity and PD (Pharmacodynamic(s)) of BI 690517 after multiple dosing. For the FE (food effect) part, the secondary objective is to investigate the relative bioavailability of BI 690517 under fasted conditions (Reference, R) compared to BI 690517 (single dose) after a high fat high caloric breakfast (Test, T).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
once daily
once daily
Fasting
Non- fasting
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany
[N (%)] of subjects with drug-related Adverse Events
\[N (%)\] of subjects with drug-related Adverse Events
Time frame: Day 30
AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose [AUCtau,1 will be AUC0-24])
AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose \[AUCtau,1 will be AUC0-24\])
Time frame: 0-24 hours
Cmax (maximum measured concentration of the analyte in plasma) (After the first dose)(Multiple rising dose part)
Cmax (maximum measured concentration of the analyte in plasma) (After the first dose)(Multiple rising dose part)
Time frame: up to 24 hours
AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)
AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)
Time frame: 312 - 360 hours
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)
Time frame: after 312 hours and up to 360 hours
Cmax (maximum measured concentration of the analyte in plasma) (Food effect part)
Cmax (maximum measured concentration of the analyte in plasma) (Food effect part)
Time frame: Up to 48 hours
AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 48 hours
AUC0- tz (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 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Time frame: Up to 48 hours
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