Study to evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion and mass balance of parent compound and radioactivity at steady-state; to isolate, identify and quantify major metabolites of tipranavir in plasma, urine and feces
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Radioactive levels of 14C-Tipranavir in plasma and blood
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Radioactive erythrocyte-plasma partition ratio
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Maximum measured concentration of the analyte in plasma (Cmax)
14C-radiolabeled Tipranavir + Tipranavir
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Plasma concentration 12 hours after dosing (Cp12h)
14C-radiolabeled Tipranavir + Tipranavir
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Area under plasma concentration time curve (AUC)
14C-radiolabeled Tipranavir + Tipranavir
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Time of maximum concentration (Tmax)
14C-radiolabeled Tipranavir + Tipranavir
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Apparent terminal half life (t1/2)
14C-radiolabeled Tipranavir + Tipranavir
Time frame: -10 minutes, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, and 12 hours after dose administration
Cumulative amount of 14C- radioactivity in Urine and feces
Time frame: up to 15 days
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Percent excretion in urine and feces
relative to total radioactivity administered
Time frame: up to 15 days
Time needed to achieve steady-state as determined by tipranavir trough concentrations
Time frame: up to 15 days
Number of subjects with adverse events
Time frame: up to 15 days
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to day 14
Number of subjects with clinically significant changes in Electrocardiogram (ECG)
Time frame: up to day 6