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

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Male Subjects

Treatments: Drug: [14C]ONO-4053

Study type: Interventional

Funder types: Industry

Identifiers

NCT01909986

ONO-4053POE004

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: Male

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

8 participants in 1 patient group

E1

Experimental group

Description:

\[14C\]-ONO-4053

Treatment:

Drug: [14C]ONO-4053