The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male and female subjects following oral administration of multiple rising doses over 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
tablet
tablet
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany
Percentage of participants with drug-related adverse events
Percentage of participants with drug-related adverse events.
Time frame: From first intake of trial medication until 21 days (Residual Effect Period) after the last drug administration, up to 49 days.
Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose (AUCτ,1)
Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose (AUCτ,1).
Time frame: Within 3 hours (h) before the first drug administration and 1, 2, 4, 6, 8, 10, 12, 14, 24 hours afterwards.
Maximum measured concentration of the analyte in plasma after administration of the first dose (Cmax,1)
Maximum measured concentration of the analyte in plasma after administration of the first dose (Cmax,1).
Time frame: Within 3 hours (h) before the first drug administration and 1, 2, 4, 6, 8, 10, 12, 14, 24 hours afterwards.
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (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: Within 15 minutes prior to last drug administration (timepoint of last drug administration: 648 hours after first drug administration) and 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours after the last drug administration.
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss).
Time frame: Within 15 minutes prior to last drug administration (timepoint of last drug administration: 648 hours after first drug administration) and 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours after last drug administration.
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