Healthy Adult Male SubjectsPhase 1NCT01909986
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
A Phase 1 study testing [14C]ONO-4053 in people with Healthy Adult Male Subjects, run by Ono Pharmaceutical Co., Ltd. at 1 site in United Kingdom.
Trial summary
This is a single dose mass balance study in healthy adult male volunteers to investigate the metabolism and excretion of [14C]-ONO-4053. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male Subjects
- What is being tested?
- [14C]ONO-4053
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject has provided written informed consent
- Healthy male subjects aged 35 to 65 years inclusive
- 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
Who cannot join
- The Investigator deems the subject unsuitable for the study
- 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
- The subject has a history of acute gastrointestinal illness
- The subject has used prescription medicine, non-prescription medicine, vitamins, herbal treatments or dietary supplements within 14 days of dosing.
- Current smokers and those who have smoked within the last 12 months
- 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 locations and contacts
1 site in 1 country.
About this study
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
This is a single dose mass balance study in healthy adult male volunteers to investigate the metabolism and excretion of [14C]-ONO-4053.
Read the 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
- Being tested
- [14C]ONO-4053
- Keywords
- ONO-4053, Healthy adult male subjects, pharmacokinetics, metabolism, excretion, mass balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]ONO-4053Drug
Single dose [14C]ONO-4053
| Study group | Role | What they receive |
|---|---|---|
| E1 | Experimental | [14C]-ONO-4053 Receives: Drug: [14C]ONO-4053 |
What is being measured
The primary outcome is the main question the study is designed to answer.
[14C]ONO-4053 recovery
Total recovery of radioactivity in urine and faeces expressed as a percentage of the total radioactive dose administered
Measured: 11 Days
Secondary outcomes (6)
[14C]-ONO-4053 metabolites
Characterisation and identification of [14C]-ONO-4053 metabolites in plasma, urine and faeces.
Measured: 11 Days
Total drug-related material
PK parameters of total drug-related material (radioactivity) in blood and plasma
Measured: 11 Days
ONO-4053 in plasma
PK parameters of ONO-4053 in plasma
Measured: 11 Days
Blood:plasma ratio of [14C]ONO-4053
Blood:plasma ratio of total drug-related material (radioactivity)
Measured: 11 Days
Radioactivity in urine
PK parameter of total radioactivity in urine
Measured: 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.
Measured: 14 - 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male SubjectsStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Department, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909986
- Sponsor's protocol ID
- ONO-4053POE004
- Status last verified
- Jul 2013
- First submitted
- 8 Jul 2013
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01909986
- Acronym / sponsor ID
- ONO-4053POE004
- Conditions
- Healthy Adult Male Subjects
- Keywords
- ONO-4053, Healthy adult male subjects, pharmacokinetics, metabolism, excretion, mass balance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E1 | Experimental | Drug: [14C]ONO-4053[14C]-ONO-4053 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject has provided written informed consent
- Healthy male subjects aged 35 to 65 years inclusive
- 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
Key exclusion criteria (6 listed)
- The Investigator deems the subject unsuitable for the study
- 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
- The subject has a history of acute gastrointestinal illness
- The subject has used prescription medicine, non-prescription medicine, vitamins, herbal treatments or dietary supplements within 14 days of dosing.
- Current smokers and those who have smoked within the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]ONO-4053Single dose [14C]ONO-4053 | Drug | E1 |
Primary outcome
[14C]ONO-4053 recovery
Time frame: 11 Days
Total recovery of radioactivity in urine and faeces expressed as a percentage of the total radioactive dose administered
6 secondary outcomes
[14C]-ONO-4053 metabolites
Time frame: 11 Days
Total drug-related material
Time frame: 11 Days
ONO-4053 in plasma
Time frame: 11 Days
Blood:plasma ratio of [14C]ONO-4053
Time frame: 11 Days
Radioactivity in urine
Time frame: 11 Days
Safety and tolerability parameters
Time frame: 14 - 16 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Department study director
Ono Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]ONO-4053 in people with Healthy Adult Male Subjects, run by Ono Pharmaceutical Co., Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[14C]ONO-4053 recovery (time frame: 11 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014; AzTrials last refreshed its copy on 6 Nov 2026.