Healthy Adult Male Subjects Clinical Trial
Official title:
An Open Label, Single-dose Study to Evaluate the Pharmacokinetics, Metabolism and Excretion Balance of [14C]-ONO-4053 in Healthy Adult Male Subjects
This is a single dose mass balance study in healthy adult male volunteers to investigate the metabolism and excretion of [14C]-ONO-4053.
This is a single centre, open-label, non-randomised study in healthy adult male subjects. Six subjects will receive a single dose of 14C ONO-4053 administered orally as a suspension. Safety measurements (ECG, vital signs, biochemistry and haematology) and adverse events will be monitored throughout the study. After administration of 14C ONO-4053 subjects will remain in the clinical facility for collection of blood, urine and faecessamples. Samples will be analysed for recovery of radioactivity and characterisation of metabolites of ONO-4053. ;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label