The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3814916 in healthy male and female trial participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
136
BI 3814916
Placebo matching BI 3814916
SGS Life Science Services - Clinical Research
Edegem, Belgium
RECRUITINGOccurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator
Time frame: up to 111 days
Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 72 days
Part A: Maximum measured concentration of the analyte in serum (Cmax)
Time frame: up to 72 days
Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss), if steady state can be reasonably assumed
Time frame: up to 108 days
Part B: Maximum measured concentration of the analyte in serum at steady state (Cmax,ss), if steady state can be reasonably assumed
Time frame: up to 108 days
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