The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK), dose proportionality, the attainment of steady state, as well as investigation of linearity and pharmacodynamics (PD) of BI 685509 after multiple dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany
Percentage of subjects with drug-related Adverse Events
Time frame: 5 weeks
AUC tau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose) [AUC tau,1 will be AUC0-24 for QD]
Time frame: up to 24 hours
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours
AUC tau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau) [AUC tau,ss will be AUC0-12,ss for bid and AUC0-24,ss for QD]
Time frame: up to 408 hours
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau)
Time frame: up to 408 hours
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