A study in healthy man to investigate the absolute bioavailability of 100mg BI 765080, once administered as subcutaneous (SC) injection and once administered as intravenous infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
BI 765080
SGS Life Science Services - Clinical Research
Edegem, Belgium
Area Under the Concentration-time Curve of BI 765080 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 765080 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
Time frame: Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)"
Maximum Measured Concentration of BI 765080 in Plasma (Cmax)
Maximum measured concentration of BI 765080 in plasma (Cmax) is reported.
Time frame: Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)".
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Time frame: Within 3 hours (h) before and 0.5h, 2h, 4h, 8h, 12h, 24h, 34h, 48h, 72h, 96h*, 120h, 168h, 240h, 312h, 480h, 648h and 1320h after administration of BI 765080. * Applicable only for the arm "100 mg BI 765080 SC injection (T)".
Occurrence of Drug-related Adverse Events
Percentage of participants with drug-related adverse events is reported.
Time frame: From start of drug of administration until end of trial, up to 59 days.
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