A Study to Determine the Excretion Balance and Pharmacokinetics of 14C-GSK573719
Status:
Completed
Trial end date:
2011-06-22
Target enrollment:
Participant gender:
Summary
This will be a two-period, open-label study conducted at a single site. Six healthy male
subjects will participate in the study to ensure at least four fully evaluable subjects. Each
subject will receive a single 1000 μg (microgram) oral dose containing 50 μCi (Micro Curie)
of [14C]-GSK573719 and a 65 μg intravenous infusion containing 7.1 μCi of [14C]-GSK573719.
Whilst subjects are in-house, urine and faecal samples will be collected for a minimum of 168
hours (7 days) after dosing or for up to 240 hours (10 days) depending on the amounts of
radioactivity still being excreted after Day 5. Faecal sample collection may continue at home
for up to 14 days. Bile samples will be collected using Entero-Test string sampling of
duodenal bile. Whole blood and plasma samples will be collected at various sample times after
dosing to measure parent drug (plasma only) and total radiolabelled drug related material
(blood and plasma). Urine and faeces aliquots will be taken to measure total radiolabelled
drug-related material. Samples of urine, faeces and plasma will be transferred into a
separate study to characterize and, where possible, quantify metabolites in these matrices.