Inflammatory Bowel DiseasePhase 1NCT01666327
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease
A Phase 1 study testing MT-1303 in people with Inflammatory Bowel Disease, run by Tanabe Pharma Corporation at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- MT-1303
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Jul 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A body mass index (BMI) ranging from 16 to 34 kg/m2
- Subjects who were diagnosed as Crohn's Disease or Ulcerative Colitis at least 6 months prior to Screening, clinically confirmed either by radiological, endoscopic or histological examination.
- Subjects who have had at least one flare within 18 months prior to Screening.
- Confirmed medical records of inflammatory lesions in intestinal tract
Who cannot join
- Present or past history of clinically significant gastrointestinal surgery.
- Present or past history of clinically significant stenosis, stricture or fistula in small intestine or colon.
- Known hypersensitivity to any formulation excipients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Evaluate the Safety, Tolerability, Pharmacodynamics of a Single Oral Dose of MT-1303 in Subjects With Inflammatory Bowel Disease.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease.
Read the detailed description
This is an open-label, non-randomised, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MT-1303 in subjects with inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis).
- Conditions
- Inflammatory Bowel Disease
- Being tested
- MT-1303
- Keywords
- Crohn's Disease, Ulcerative Colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-1303Drug
| Study group | Role | What they receive |
|---|---|---|
| MT-1303 | Experimental | Not described Receives: Drug: MT-1303 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events
Measured: 1month
Peak plasma concentration (Cmax) of MT-1303 and its metabolite
Measured: 15 time points up to 1 month
Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite
Measured: 15 time points up to 1 month
Secondary outcomes (3)
Pharmacodynamic effect of MT-1303 on lymphocyte count
Measured: 16 time points up to 1 month
Exploratory parameter : C-reactive protein (CRP)
Measured: 4 time points up to 1 week
Exploratory parameter :Erythrocyte sedimentation (ESR)
Measured: 4 time points up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666327
- Sponsor's protocol ID
- MT-1303-E03
- Status last verified
- Sep 2014
- First submitted
- 8 Aug 2012
- Last updated
- 5 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety, Tolerability, Pharmacodynamics of a Single Oral Dose of MT-1303 in Subjects With Inflammatory Bowel Disease.
- ClinicalTrials.gov ID
- NCT01666327
- Acronym / sponsor ID
- MT-1303-E03
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Crohn's Disease, Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Aug 2012 (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.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease.
Detailed description
This is an open-label, non-randomised, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MT-1303 in subjects with inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MT-1303 | Experimental | Drug: MT-1303 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A body mass index (BMI) ranging from 16 to 34 kg/m2
- Subjects who were diagnosed as Crohn's Disease or Ulcerative Colitis at least 6 months prior to Screening, clinically confirmed either by radiological, endoscopic or histological examination.
- Subjects who have had at least one flare within 18 months prior to Screening.
- Confirmed medical records of inflammatory lesions in intestinal tract
Key exclusion criteria (3 listed)
- Present or past history of clinically significant gastrointestinal surgery.
- Present or past history of clinically significant stenosis, stricture or fistula in small intestine or colon.
- Known hypersensitivity to any formulation excipients.
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 |
|---|---|---|
| MT-1303 | Drug | MT-1303 |
Primary outcome
Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events
Time frame: 1month
Peak plasma concentration (Cmax) of MT-1303 and its metabolite
Time frame: 15 time points up to 1 month
Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite
Time frame: 15 time points up to 1 month
3 secondary outcomes
Pharmacodynamic effect of MT-1303 on lymphocyte count
Time frame: 16 time points up to 1 month
Exploratory parameter : C-reactive protein (CRP)
Time frame: 4 time points up to 1 week
Exploratory parameter :Erythrocyte sedimentation (ESR)
Time frame: 4 time points up to 1 week
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 5 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 MT-1303 in people with Inflammatory Bowel Disease, run by Tanabe Pharma Corporation 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 4 inclusion and 3 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 5 Sep 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?
Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events (time frame: 1month). 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 5 Sep 2014.