Single dose (SD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of single dose. Multiple doses (MD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of multiple doses. Oral contraceptives (OC) part: The main objective of this trial is to investigate the effect of multiple oral doses of BI 3031185 on pharmacokinetics of drospirenone (DRSP) and ethinylestradiol (EE) (YAZ®) in Japanese healthy female trial participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
BI 3031185
Placebo matching BI 3031185
Midazolam
YAZ®
Fukuoka Mirai Hospital
Fukuoka, Fukuoka, Japan
SD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
SD = Single dose
Time frame: Up to 29 days
MD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
MD = Multiple doses
Time frame: Up to 47 days
OC part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
OC = Oral contraceptives
Time frame: Up to 29 days
OC part: Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 29 days
SD 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 11 days
SD part: Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: Up to 11 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)
Time frame: Up to 39 days
MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: Up to 39 days
OC part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: Up to 29 days
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