The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
83
BI 1569912
Placebo
Charité - Universitätsmedizin Berlin
Berlin, Germany
Number of Subjects With Drug-related Adverse Events
Number of subjects with drug-related adverse events is reported.
Time frame: Up to Day 27
Area Under the Concentration-time Curve of BI 1569912 in Plasma Over a Uniform Dosing Interval of 24 h After Administration of the First Dose (AUC0-24)
Area under the concentration-time curve of BI 1569912 in plasma over a uniform dosing interval of 24 h after administration of the first dose (AUC0-24) is reported.
Time frame: Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.
Maximum Measured Concentration of BI 1569912 in Plasma After the First Dose (Cmax)
Maximum measured concentration of BI 1569912 in plasma after the first dose (Cmax) is reported.
Time frame: Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.
Area Under the Concentration-time Curve of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Last Dose
Area under the concentration-time curve of BI 1569912 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after the last dose is reported.
Time frame: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.
Maximum Measured Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Last Dose
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Maximum measured concentration of BI 1569912 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after the last dose is reported.
Time frame: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.
Minimum Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) After the Last Dose
Minimum concentration of BI 1569912 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) after the last dose is reported.
Time frame: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.
Accumulation Ratio Based on Cmax,ss (RA,Cmax) After the Last Dose
Accumulation ratio based on Cmax,ss (RA,Cmax) after the last dose is reported. The BI 1569912 elderly 10/20 mg treatment group was not analysed for this endpoint because dose was changed on Day 1 and Day 14.
Time frame: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14.
Accumulation Ratio Based on AUC0-τ (RA,AUC) After the Last Dose
Accumulation ratio based on AUC0-τ 0 to tau (RA,AUC) after the last dose is reported. The BI 1569912 elderly 10/20 mg treatment group was not analysed for this endpoint because dose was changed on Day 1 and Day 14.
Time frame: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14.