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

Study Overview
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Brief Summary
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This is a single dose mass balance study in healthy adult male volunteers to investigate the metabolism and excretion of [14C]-ONO-4053.

Detailed Description
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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.

Official Title
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An Open Label, Single-dose Study to Evaluate the Pharmacokinetics, Metabolism and Excretion Balance of [14C]-ONO-4053 in Healthy Adult Male Subjects

Conditions
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Healthy Adult Male Subjects

Intervention / Treatment
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* Drug: [14C]ONO-4053


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E1<br>[14C]-ONO-4053 | Drug: [14C]ONO-4053<br>* Single dose [14C]ONO-4053<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [14C]ONO-4053 recovery | Total recovery of radioactivity in urine and faeces expressed as a percentage of the total radioactive dose administered | 11 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [14C]-ONO-4053 metabolites | Characterisation and identification of [14C]-ONO-4053 metabolites in plasma, urine and faeces. | 11 Days | 
| Total drug-related material | PK parameters of total drug-related material (radioactivity) in blood and plasma | 11 Days | 
| ONO-4053 in plasma | PK parameters of ONO-4053 in plasma | 11 Days | 
| Blood:plasma ratio of [14C]ONO-4053 | Blood:plasma ratio of total drug-related material (radioactivity) | 11 Days | 
| Radioactivity in urine | PK parameter of total radioactivity in urine | 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. | 14 - 16 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONO-4053, Healthy adult male subjects, pharmacokinetics, metabolism, excretion, mass balance