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

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

Study Overview

• Status: Completed
• Conditions: Healthy Adult Male Subjects
• Intervention / Treatment: Drug: [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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Nottingham Clinical SIte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. The subject has provided written informed consent
2. Healthy male subjects aged 35 to 65 years inclusive
3. 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:

1. The Investigator deems the subject unsuitable for the study
2. 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
3. The subject has a history of acute gastrointestinal illness
4. The subject has used prescription medicine, non-prescription medicine, vitamins, herbal treatments or dietary supplements within 14 days of dosing.
5. Current smokers and those who have smoked within the last 12 months
6. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E1; [14C]-ONO-4053	Drug: [14C]ONO-4053; Single dose [14C]ONO-4053

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Clinical Department, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 26, 2013
• First Posted (Estimate): July 29, 2013

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: pharmacokinetics; metabolism; mass balance; excretion; ONO-4053; Healthy adult male subjects
• Other Study ID Numbers: ONO-4053POE004