The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
SGS Life Science Services - Clinical Research
Edegem, Belgium
Percentage of subjects with drug-related adverse events
Time frame: Up to day 20
Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12)
Time frame: Up to 12 hours
Maximum measured concentration BI 3000202 in plasma (Cmax)
Time frame: Up to 24 hours
Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state
Time frame: Up to day 20
Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state
Time frame: Up to day 20
Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state
Time frame: Up to day 20
Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after a single dose
Time frame: Up to 2 days
Maximum measured concentration of midazolam in plasma (Cmax) after a single dose
Time frame: Up to 2 days
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