The primary objective of this trial is to investigate the safety and tolerability of BI 1265162 in healthy male subjects following inhalative administration of single rising doses. Secondary objective is the exploration of the pharmacokinetics (PK) of BI 1265162 after single dosing.
To investigate safety, tolerability and pharmacokinetics of BI 1265162 in man.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
57
Single rising dose groups
Single rising dose groups
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany
Percentage of Participants With Drug-related Adverse Events (AEs)
Percentage of participants with drug-related adverse events (AEs).
Time frame: From drug administration until end of trial examination, up to 9 days
Maximum Measured Concentration of BI 1265162 in Plasma (Cmax)
Maximum measured concentration of BI 1265162 in plasma (Cmax).
Time frame: Pharmacokinetic samples were taken pre-dose and 0:02 (hour: minute), 0:05, 0:10, 0:15, 0:20 , 0:30, 0:45, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 48:00 and 72:00 (Last time point only taken for 1200 µg) after drug administration
Area Under the Concentration-time Curve of the BI 1265162 in Plasma Over the Time Interval 0 to 1 Hour Post-dose (AUC0-1)
Area under the concentration-time curve of the BI 1265162 in plasma over the time interval 0 to 1 hour post-dose (AUC0-1)
Time frame: Pharmacokinetic samples were taken pre-dose and 0:02 (hour: minute), 0:05, 0:10, 0:15, 0:20 , 0:30, 0:45, 1:00 after drug administration
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