A Human Mass Balance Study to Determine the Total Recovery of Radioactivity in Urine and Faeces Following a Single Oral Dose of 14C Radiolabelled 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.

Inclusion criteria

• The subject has provided written informed consent
• Healthy male subjects aged 35 to 65 years inclusive
• Subject is not trying to father a child and is willing to use one of the contraception methods listed in the protocol 4 The subject has a body mass index of 19.0 to 30.0 kg/m2 inclusive. 5 The subject is healthy as determined by the Investigator 6 Regular daily bowel movements

Exclusion criteria

• The Investigator deems the subject unsuitable for the study
• The subject has, or has a history of, any significant disease or disorder (including any clinically significant laboratory findings) that would increase the risk for the subject if they were enrolled in the study
• The subject has a history of acute gastrointestinal illness
• The subject has used prescription medicine, non-prescription medicine, vitamins, herbal treatments or dietary supplements within 14 days of dosing.
• Current smokers and those who have smoked within the last 12 months
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.