Bacterial EnteritisPhase 1NCT02440633
A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects
A Phase 1 study testing 14C-OPS-2071 in people with Bacterial Enteritis, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in United Kingdom.
Trial summary
To obtain absorption, metabolism and excretion data for parent drug and any metabolites. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Enteritis
- What is being tested?
- 14C-OPS-2071
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Aug 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Who cannot join
- Subjects who have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator.
- Subjects who smoke, or who have used nicotine within 3 months prior to screening..
- Subjects who have a significant history of drug allergy, as determined by the Investigator.
- Subjects who have any clinically significant abnormal physical examination finding.
- Subjects who have any clinically significant medical history, as determined by the Investigator.
- Subjects who are exposed to radiation as a result of their occupation.
- Subjects who have had an X ray or CT scan, or who have participated in any trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.
Trial locations and contacts
1 site in 1 country.
About this study
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
- Conditions
- Bacterial Enteritis
- Being tested
- 14C-OPS-2071
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-OPS-2071Drug
Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.
| Study group | Role | What they receive |
|---|---|---|
| 14C-OPS-2071 | Experimental | Suspension containing 50 mg of 14C-OPS-2071 Receives: Drug: 14C-OPS-2071 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Amounts of Radioactivity Excreted in Urine and Faeces
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.
Measured: up to144-168h postdose.
Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.
Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
AUC of OPS-2071 in Plasma
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.
Measured: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial EnteritisStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshitaka Kotobuki, Study director, Small Global, Division of New Product Evaluation and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440633
- Sponsor's protocol ID
- 341-14-001
- Status last verified
- Aug 2016
- First submitted
- 1 May 2015
- Last updated
- 21 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects
- ClinicalTrials.gov ID
- NCT02440633
- Acronym / sponsor ID
- 341-14-001
- Conditions
- Bacterial Enteritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Posted 24 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-OPS-2071 | Experimental | Drug: 14C-OPS-2071Suspension containing 50 mg of 14C-OPS-2071 |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males
- Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Key exclusion criteria (7 listed)
- Subjects who have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator.
- Subjects who smoke, or who have used nicotine within 3 months prior to screening..
- Subjects who have a significant history of drug allergy, as determined by the Investigator.
- Subjects who have any clinically significant abnormal physical examination finding.
- Subjects who have any clinically significant medical history, as determined by the Investigator.
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-OPS-2071Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly. | Drug | 14C-OPS-2071 |
Primary outcome
The Amounts of Radioactivity Excreted in Urine and Faeces
Time frame: up to144-168h postdose.
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.
Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood
Time frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.
AUC of OPS-2071 in Plasma
Time frame: predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.
A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yoshitaka Kotobuki study director
Small Global, Division of New Product Evaluation and Development
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-OPS-2071 in people with Bacterial Enteritis, run by Otsuka 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 7 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 21 Oct 2016. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Amounts of Radioactivity Excreted in Urine and Faeces (time frame: up to144-168h postdose.). The study lists 3 primary outcomes in all. 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 21 Oct 2016.