Effects of multiple rising doses of BI 1839100 on safety, tolerability, pharmacokinetics and the effect of high-fat meal on pharmacokinetics of BI 1839100 will be assessed as well as assessing potential drug-drug interactions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
67
ICON-Groningen-62040
Groningen, Netherlands
MRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Multiple-rising dose (MRD)
Time frame: up to 26 days
DDI part: Area under the concentration-time curve of midazolam, digoxin and rosuvastatin when administered without BI 1839100 over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Drug-Drug Interaction (DDI)
Time frame: up to 20 days
DDI part: Maximum measured concentration of midazolam, digoxin and rosuvastatin when administered without BI 1839100 in plasma (Cmax)
Time frame: up to 20 days
DDI part: Area under the concentration-time curve of midazolam, digoxin and rosuvastatin when co-administered with BI 1839100 over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to 7 days
DDI part: Maximum measured concentration of midazolam, digoxin and rosuvastatin when co-administered with BI 1839100 in plasma (Cmax)
Time frame: up to 7 days
MRD part: Maximum measured concentration of the analyte in plasma after single dose (Cmax)
Time frame: at Day 1
MRD part: Time from dosing to maximum measured concentration of the analyte in plasma (tmax)
Time frame: at Day 1
MRD part: Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 12 hours (AUC0-12)
Time frame: at Day 1
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digoxin
rosuvastatin
MRD part: Area under the concentration-time curve of the analyte in plasma over the time interval 0 to 48 hours (AUC0-48)
Time frame: up to 48 hours
MRD part: Area under the concentration-time curve of the analyte in plasma over a uniform 12 hours dosing interval (τ) [after Nth dose] (AUCτ( ,N))
Time frame: up to 17 days
MRD part: Maximum measured concentration of the analyte in plasma [after Nth dose] (Cmax( ,N))
Time frame: up to 17 days