This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
BI 3031185
Placebo
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
SRD part: The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
Time frame: Up to 22 days
FE part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)
Time frame: Up to 24 hours
FE part: Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 8 days
SRD part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)
Time frame: Up to 24 hours
SRD part: Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 13 days
FE part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 8 days
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