To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]SB-681323 in Healthy Adult Males
Status:
Completed
Trial end date:
2007-10-26
Target enrollment:
Participant gender:
Summary
SB-681323 is a p38 MAP kinase inhibitor and is currently under development by
GlaxoSmithKline. 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 10mg/ 50 µCurie oral dose of [14C]SB-681323. Urine and faecal samples will
be collected until 216 h after dosing but subjects may be discharged after 168 h if 90% of
the dose is recovered and/or <1% of the dose is excreted in a 24 h 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 separate
study to characterise and quantify metabolites in these matrices. Safety will be assessed by
adverse event monitoring, vital signs, ECG and clinical laboratory tests.