Status:
COMPLETED
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
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Healthy Adult Male Subjects
Eligibility:
MALE
35-65 years
Phase:
PHASE1
Brief Summary
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
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 measuremen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01909986
Start Date
October 1 2013
Last Update
April 15 2014
Active Locations (1)
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1
Nottingham Clinical site
Nottingham, United Kingdom, NG11 6JS