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

NCT01909986 | Completed Phase 1

• 1 other identifier: ONO-4053POE004
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Male Subjects

Keywords

ONO-4053; Healthy adult male subjects; pharmacokinetics; metabolism; excretion; mass balance

Outcome Measures

Primary Outcomes (1)

• [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 Outcomes (6)

• [14C]-ONO-4053 metabolites

  11 Days

• Total drug-related material

  11 Days

• ONO-4053 in plasma

  11 Days

• Blood:plasma ratio of [14C]ONO-4053

  11 Days

• Radioactivity in urine

  11 Days

Study Arms (1)

E1

EXPERIMENTAL

\[14C\]-ONO-4053

Drug: [14C]ONO-4053

Interventions

[14C]ONO-4053 DRUG

Single dose \[14C\]ONO-4053

E1

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (1)

Nottingham Clinical site

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Clinical Department

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 29, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2013-07

Locations

GB (1)