Assessment of the effect of different boosting agents on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Maximum observed concentration of the analyte in the plasma (Cmax)
Time frame: up to 120 hours after start of treatment
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time frame: up to 120 hours after start of treatment
Area under the concentration-time curve of the analyte in plasma at different time points (AUC)
Time frame: up to 120 hours after start of treatment
Apparent terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 120 hours after start of treatment
Apparent clearance of the analyte in plasma after extravascular multiple dose administration (CL/F)
Time frame: up to 120 hours after start of treatment
Total mean residence time of the analyte in the body (MRTtot)
Time frame: up to 120 hours after start of treatment
Apparent volume of distribution of the analyte during the terminal phase λz following extravascular administration (Vz/F)
Time frame: up to 120 hours after start of treatment
Renal clearance of the analyte determined over the dosing interval τ (CLR)
Time frame: up to 120 hours after start of treatment
Amount of the analyte excreted into urine (Ae)
Time frame: up to 72 hours after start of treatment
Number of participants with clinically relevant changes in laboratory parameters
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Time frame: up to 10 days after start of treatment
Number of participants with clinically relevant changes in vital signs (blood pressure, pulse-, respiratory rate, body temperature)
Time frame: up to 10 days after start of treatment
Number of participants with clinically relevant changes in 12-lead ECG
Time frame: up to 10 days after start of treatment
Number of participants with clinically relevant changes in faecal occult blood testing
Time frame: up to 10 days after start of treatment
Number of participants with adverse events
Time frame: Up to 25 days
Global tolerability assessment by investigator on a 5-point scale
Time frame: Up to 10 days after start of treatment
Number of participants with clinically relevant changes in neurological assessment
Assessment of central nervous system function including Romberg's test, heel-to-toe straight line, and finger-nose tests
Time frame: up to 10 days after start of treatment