Relapsing-remitting Multiple SclerosisPhase 1NCT02293967
Mass Balance Study of MT-1303
A Phase 1 study testing MT-1303 in people with Relapsing-remitting Multiple Sclerosis, run by Tanabe Pharma Corporation at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- MT-1303
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Dec 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian male aged 30 to 65 at Screening.
- Body weight of ≥60 kg, and a BMI ranging from 18.0 to 32.0 kg/m2 at Screening and Day -1.
- Normal or not clinically significant ECG as defined by a HR between 50 and 100 bpm inclusive at Screening, Day -1 and pre-dose.
- Vital signs within the following ranges at Screening and Day -1,Body temperature: 35.0 to 37.5 °C,SBP: 90 to 140 mmHg,DBP: 50 to 90 mmHg.
- Regular daily bowel movements.
Who cannot join
- 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.
- Previous medical history of tuberculosis, or in the opinion of the Investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. The investigator should be guided by evidence of any of the following:
- history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding;
- history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- MT-1303
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
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 | [14C] MT-1303 after a single oral dose Receives: Drug: MT-1303 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity in urine and faeces
Measured: up to 10 weeks
Secondary outcomes (1)
PK of total radioactivity in plasma
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing-remitting Multiple SclerosisStudies 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
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pui Leung, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293967
- Sponsor's protocol ID
- MT-1303-E11
- Status last verified
- Mar 2015
- First submitted
- 14 Nov 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
Publications
Kifuji T, Inoue S, Furukawa M, Perez Madera B, Goto T, Kumagai H, Mair SJ, Kawaguchi A. Absorption, disposition and metabolic pathway of amiselimod (MT-1303) in healthy volunteers in a mass balance study. Xenobiotica. 2019 Sep;49(9):1033-1043. doi: 10.1080/00498254.2018.1525508. Epub 2018 Dec 21.
PubMed 30231665
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT02293967
- Acronym / sponsor ID
- MT-1303-E11
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Nov 2014 (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 investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.
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[14C] MT-1303 after a single oral dose |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Caucasian male aged 30 to 65 at Screening.
- Body weight of ≥60 kg, and a BMI ranging from 18.0 to 32.0 kg/m2 at Screening and Day -1.
- Normal or not clinically significant ECG as defined by a HR between 50 and 100 bpm inclusive at Screening, Day -1 and pre-dose.
- Vital signs within the following ranges at Screening and Day -1,Body temperature: 35.0 to 37.5 °C,SBP: 90 to 140 mmHg,DBP: 50 to 90 mmHg.
- Regular daily bowel movements.
Key exclusion criteria (5 listed)
- 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.
- Previous medical history of tuberculosis, or in the opinion of the Investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. The investigator should be guided by evidence of any of the following:
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
Total radioactivity in urine and faeces
Time frame: up to 10 weeks
1 secondary outcome
PK of total radioactivity in plasma
Time frame: up to 10 weeks
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 17 Mar 2015.
- Derived from this study: PubMed 30231665Kifuji T, Inoue S, Furukawa M, Perez Madera B, Goto T, Kumagai H, Mair SJ, Kawaguchi A. Absorption, disposition and metabolic pathway of amiselimod (MT-1303) in healthy volunteers in a mass balance study. Xenobiotica. 2019 Sep;49(9):1033-1043. doi: 10.1080/00498254.2018.1525508. Epub 2018 Dec 21.
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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.
Pui Leung principal investigator
Quotient Clinical
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 Relapsing-remitting Multiple Sclerosis, 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 5 inclusion and 5 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 17 Mar 2015. 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?
Total radioactivity in urine and faeces (time frame: up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02293967, which also lists 1 linked publication.
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 17 Mar 2015.