NCT01909986

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Healthy Adult Male Subjects

Interventions

Type	Name	Description
DRUG	[14C]ONO-4053	Single dose \[14C\]ONO-4053

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-02-01
• First posted: 2013-07-29
• Last updated: 2014-04-15

Locations

1 site across 1 country: United Kingdom