The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
1344.2.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
frequency [N (%)] of subjects with drug-related adverse events
Time frame: days 1 to 24
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose
Time frame: 0 to 336 hours
Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose
Time frame: 0 to 336 hours
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
Time frame: 0 to 336 hours
Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose
Time frame: 0 to 336 hours
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose
Time frame: 0 to 336 hours
AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose
Time frame: 0 to 336 hours
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