The main objectives of this trial are to investigate safety, tolerability. pharmacokinetics (PK), and pharmacodynamics of BI 1815368 in healthy Japanese male subjects following administration of single rising doses or multiple doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
BI 1815368
Placebo matching BI 1815368
SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, Japan
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: Up to 26 days
SRD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Single-rising dose (SRD)
Time frame: Up to 6 days
SRD part: Maximum measured concentration of the analyte in plasma (Cmax)
Single-rising dose (SRD)
Time frame: Up to 6 days
MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
Multiple dose (MD)
Time frame: Up to 19 days
MD part: Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Multiple dose (MD)
Time frame: Up to 19 days
MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Multiple dose (MD)
Time frame: Up to 19 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.