To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]GW856553 in Healthy Adult Males
Status:
Completed
Trial end date:
2008-02-18
Target enrollment:
Participant gender:
Summary
This will be an open label study conducted at one site. Six healthy male subjects will be
enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single
10 milligram (mg) oral dose of GW856553 containing 50 microCi (µCi) of [14C] GW856553. Urine
and fecal samples will be collected until 216 hour after dosing but subjects may be
discharged after 168 hour if 90% of the dose is recovered and/or <1% of the dose is excreted
in a 24 hour period. Blood and plasma will be collected at various sample times after dosing
to measure parent drug and total drug-related material. Samples of urine, faeces and plasma
will be transferred into a separate study to characterize and quantify metabolites in these
matrices. Safety will be assessed by adverse event monitoring, vital signs, electrocardiogram
(ECG) and clinical laboratory tests.