* To investigate the safety and tolerability of BI 1026706 in male and female healthy subjects and osteoarthritis (OA) patients following oral administration of repeated rising doses * To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and female healthy subjects and OA patients * The assessment of pharmacodynamics in OA patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
Multiple Rising Doses (oral solution, tablet)
Multiple Rising Doses (oral solution / tablet, identical to active treatment)
1320.2.2 Boehringer Ingelheim Investigational Site
Berlin, Germany
Percentage of Subjects With Drug Related Adverse Events
Percentage of subjects with drug related adverse events (AEs)
Time frame: From first drug administration until 3 days after last drug administration, 15 days
Maximum Measured Concentration (Cmax)
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin
Time From Dosing to Maximum Measured Concentration (Tmax)
Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)
Time frame: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin.
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 hours (h) (AUC0-24).
Time frame: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin
Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 12 hours (h) (AUC0-12).
Time frame: 1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h and 12h after first drug admin
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Maximum Measured Concentration at Steady-state (Cmax,ss)
Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval τ (Cmax,ss).
Time frame: 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12
Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss)
Time from last dosing to maximum concentration of the analyte in plasma at steady-state (Tmax,ss).
Time frame: 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12
Area Under the Concentration-time Curve at Steady-state (AUCτ,ss)
Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ (AUCτ,ss).
Time frame: 5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12