To assess the antiviral effect, safety and pharmacokinetics of rising doses of 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 150 mg, 200 mg, 300 mg, 450 mg, 650 mg, 900 mg oral BILB 1941 ZW administered Q8H in a polyethyleneglycol 400 (PEG 400): distilled water: Tromethamine (TRIS) drinking solution for five days to patients with chronic HCV genotype 1 infection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Change in virus load (VL)
determined by IU per ml serum from baseline by \> 1.0 log10 step
Time frame: Up to day 6
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 14 days after first drug administration
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: Up to 14 days after first drug administration
AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)
Time frame: Up to 14 days after first drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 14 days after first drug administration
%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)
Time frame: Up to 14 days after first drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 14 days after first drug administration
t1/2 (terminal half-life of the analyte in plasma)
Time frame: Up to 14 days after first drug administration
CL/F (apparent clearance of the analyte in plasma after extravascular administration)
Time frame: Up to 14 days after first drug administration
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Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)
Time frame: Up to 14 days after first drug administration
Number of patients with clinically significant changes in vital signs
Time frame: Up to 14 days after first drug administration
Number of patients with clinically significant changes in body temperature
Time frame: Up to 14 days after first drug administration
Number of patients with abnormal findings in electrocardiogram (ECG)
Time frame: Up to 14 days after first drug administration
Number of patients with abnormal changes in clinical laboratory parameters
Time frame: Up to 14 days after first drug administration
Number of patients with adverse events
Time frame: Up to 14 days after first drug administration
Number of patients with abnormal findings in physical examination
Time frame: Up to 14 days after first drug administration
Investigator assessed tolerability on a 4 point scale
Time frame: Up to 14 days after first drug administration