Study to obtain information about the safety and tolerability of BIIL 248 BS, to find the pharmacologically active dose range for the two formulations PSE 1% and WIF tablets by determination of the surrogate marker CD11b (= Mac-1) and to obtain preliminary pharmacokinetic data as well as first information on food effects after administration of the 75 mg WIF tablet in healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
95
Number of subjects with clinically relevant changes in vital signs
Time frame: up to 8 days after drug administration
Number of subjects with clinically relevant changes in electrocardiogram
Time frame: up to 8 days after drug administration
Number of subjects with clinically relevant changes in laboratory parameters
Time frame: up to 8 days after drug administration
Number of subjects with adverse events
Time frame: up to 8 days after drug administration
Determination of surrogate marker cluster of differentiation antigen 11b (CD11b) (=Mac-1)
Time frame: up to 72 hours after drug administration
Changes in white blood cell count
determined by flow cytometer
Time frame: up to 48 hours after drug administration
Changes in differential blood cell count
determined by flow cytometer
Time frame: up to 48 hours after drug administration
Maximum plasma concentration (Cmax)
Time frame: up to 72 hours after drug administration
Time to reach maximum plasma concentration (tmax)
Time frame: up to 72 hours after drug administration
Area under the plasma concentration-time curve (AUC) for several time intervals
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Time frame: up to 72 hours after drug administration
Terminal half-life (t1/2)
Time frame: up to 72 hours after drug administration
Total mean residence time (MRTtot)
Time frame: up to 72 hours after drug administration
Total clearance after oral administration (CLtot/f)
Time frame: up to 72 hours after drug administration
Volume of distribution during terminal phase after oral administration (Vz/f)
Time frame: up to 72 hours after drug administration