Investigation of safety, tolerability, pharmacokinetics and pharmacodynamics of single rising doses of BI 705564 and of the food effect on BI 705564 in healthy male subjects
The primary objective of the single rising dose part under fasting and under fed conditions is to investigate safety and tolerability of BI 705564 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of pharmacokinetics (PK) including dose proportionality, and pharmacodynamics (PD) of BI 705564 after single rising doses. The objective of the food effect part is to explore the relative bioavailability of BI 705564 tablets under fed and fasted conditions following the oral administration of single doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
91
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
Number of Participants With Drug-related Adverse Events (AEs)
Number of participants with drug-related adverse events (AEs) is presented for SRD part.Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator.
Time frame: From drug administration until end of the treatment, up to 15 days (for SRD fasting and fed conditions).
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (FE Part)
AUC0-tz, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 to the last quantifiable data point for FE part is presented.
Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (FE Part)
Cmax, maximum measured concentration of BI 705564 in plasma is presented for FE part.
Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Maximum Measured Concentration of BI 705564 in Plasma (Cmax) (SRD Part)
Cmax, maximum measured concentration of BI 705564 in plasma is presented for SRD part.
Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (SRD Part)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC0-∞, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 extrapolated to infinity is presented for SRD part.
Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.
Area Under the Concentration-time Curve of BI 705564 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (FE Part)
AUC0-∞, area under the concentration-time curve of BI 705564 in plasma over the time interval from 0 extrapolated to infinity.
Time frame: Pharmacokinetic samples were collected pre-dose and at 0:30 (hour: minute), 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 after drug administration.