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

Phase 1

Completed

• Conditions: Healthy Adult Male Subjects
• Interventions: Drug: [14C]ONO-4053

• Registration Number: NCT01909986
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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 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 Timeline

• Status Verified: 2013-07
• Study First Submitted: 2013-07-08
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-29
• Study Start: 2013-10
• Primary Completion: 2014-02
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E1	[14C]ONO-4053	\[14C\]-ONO-4053

Primary Outcome Measures

Name	Time	Method
[14C]ONO-4053 recovery	11 Days	Total recovery of radioactivity in urine and faeces expressed as a percentage of the total radioactive dose administered

Secondary Outcome Measures

Name	Time	Method
[14C]-ONO-4053 metabolites	11 Days	Characterisation and identification of \[14C\]-ONO-4053 metabolites in plasma, urine and faeces.
Total drug-related material	11 Days	PK parameters of total drug-related material (radioactivity) in blood and plasma
ONO-4053 in plasma	11 Days	PK parameters of ONO-4053 in plasma
Blood:plasma ratio of [14C]ONO-4053	11 Days	Blood:plasma ratio of total drug-related material (radioactivity)
Radioactivity in urine	11 Days	PK parameter of total radioactivity in urine
Safety and tolerability parameters	14 - 16 days	Safety and tolerability parameters including collection of adverse events, physical examinations, vital signs, 12-Lead ECG and laboratory evaluations.

Trial Locations

Locations (1)

Nottingham Clinical site; 🇬🇧 Nottingham, United Kingdom