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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
8
Single dose \[14C\]ONO-4053
Nottingham Clinical site
Nottingham, United Kingdom
[14C]ONO-4053 recovery
Total recovery of radioactivity in urine and faeces expressed as a percentage of the total radioactive dose administered
Time frame: 11 Days
[14C]-ONO-4053 metabolites
Characterisation and identification of \[14C\]-ONO-4053 metabolites in plasma, urine and faeces.
Time frame: 11 Days
Total drug-related material
PK parameters of total drug-related material (radioactivity) in blood and plasma
Time frame: 11 Days
ONO-4053 in plasma
PK parameters of ONO-4053 in plasma
Time frame: 11 Days
Blood:plasma ratio of [14C]ONO-4053
Blood:plasma ratio of total drug-related material (radioactivity)
Time frame: 11 Days
Radioactivity in urine
PK parameter of total radioactivity in urine
Time frame: 11 Days
Safety and tolerability parameters
Safety and tolerability parameters including collection of adverse events, physical examinations, vital signs, 12-Lead ECG and laboratory evaluations.
Time frame: 14 - 16 days
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