Clinical trial 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
Official title: An Open Label, Single-dose Study to Evaluate the Pharmacokinetics, Metabolism and Excretion Balance of [14C]-ONO-4053 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Male Subjects
Keywords: ONO-4053
Healthy adult male subjects
pharmacokinetics
metabolism
excretion
mass balance
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2013-07-29
Enrollment: 8
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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.

Primary outcomes:
measure: [14C]ONO-4053 recovery
timeFrame: 11 Days
Secondary outcomes:
measure: [14C]-ONO-4053 metabolites
timeFrame: 11 Days
measure: Total drug-related material
timeFrame: 11 Days
measure: ONO-4053 in plasma
timeFrame: 11 Days
measure: Blood:plasma ratio of [14C]ONO-4053
timeFrame: 11 Days
measure: Radioactivity in urine
timeFrame: 11 Days
measure: Safety and tolerability parameters
timeFrame: 14 - 16 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Clinical site
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Clinical Department
role: STUDY_DIRECTOR
References: