Relapsing-remitting Multiple SclerosisPhase 1NCT02193217
A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
A Phase 1 study testing MT-1303-Low, MT-1303-High and Fingolimod 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 explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- MT-1303-Low, MT-1303-High and Fingolimod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento Jan 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy and free from clinically significant illness or disease.
- Male and female subjects of non-childbearing potential aged 18 to 55 years.
- Normal or non-clinically significant 12-lead ECG.
- Holter recording with no clinically significant abnormalities.
- Systolic blood pressure: 90 to 140 mmHg, diastolic blood pressure: 50 to 90 mmHg
Who cannot join
- A History of severe adverse reaction or allergy to any medical product.
- Clinically significant endocrine, thyroid, hepatic, respiratory, gastrointestinal, renal, cardiovascular disease, eye disorder or history of psychiatric/psychotic disorder.
- A history of tuberculosis.
- Have a positive HBsAg, HBcAb, HCVAb or HIV-1 and HIV-2 test.
- Previously having received MT-1303, fingolimod, or any other sphingosine-1-phosphate receptor modulators.
- Clinical relevant abnormal medical history, or physical findings or laboratory values.
- Clinically significant 12-lead ECG abnormalities.
- Clinical relevant abnormal findings in echocardiograph.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- MT-1303-Low, MT-1303-High, Fingolimod, Placebo
- 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-1303-LowDrug
MT-1303-HighDrug
FingolimodDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MT-1303-Low | Experimental | MT-1303-Low dose Receives: Drug: MT-1303-Low |
| MT-1303-High | Experimental | MT-1303-High dose Receives: Drug: MT-1303-High |
| Fingolimod | Active comparator | Fingolimod Receives: Drug: Fingolimod |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean hourly heart rate
Measured: up to day 42
Secondary outcomes (1)
Plasma concentration of MT-1303 and its metabolite
Measured: up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Sowood, M.D, Study director, Mitsubishi Tanabe Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193217
- Sponsor's protocol ID
- MT-1303-E12
- Status last verified
- Feb 2015
- First submitted
- 15 Jul 2014
- Last updated
- 20 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
- ClinicalTrials.gov ID
- NCT02193217
- Acronym / sponsor ID
- MT-1303-E12
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Jul 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 explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.
Study design
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MT-1303-Low | Experimental | Drug: MT-1303-LowMT-1303-Low dose |
| MT-1303-High | Experimental | Drug: MT-1303-HighMT-1303-High dose |
| Fingolimod | Active comparator | Drug: FingolimodFingolimod |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy and free from clinically significant illness or disease.
- Male and female subjects of non-childbearing potential aged 18 to 55 years.
- Normal or non-clinically significant 12-lead ECG.
- Holter recording with no clinically significant abnormalities.
- Systolic blood pressure: 90 to 140 mmHg, diastolic blood pressure: 50 to 90 mmHg
Key exclusion criteria (8 listed)
- A History of severe adverse reaction or allergy to any medical product.
- Clinically significant endocrine, thyroid, hepatic, respiratory, gastrointestinal, renal, cardiovascular disease, eye disorder or history of psychiatric/psychotic disorder.
- A history of tuberculosis.
- Have a positive HBsAg, HBcAb, HCVAb or HIV-1 and HIV-2 test.
- Previously having received MT-1303, fingolimod, or any other sphingosine-1-phosphate receptor modulators.
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-Low | Drug | MT-1303-Low |
| MT-1303-High | Drug | MT-1303-High |
| Fingolimod | Drug | Fingolimod |
| Placebo | Drug | Placebo |
Primary outcome
Mean hourly heart rate
Time frame: up to day 42
1 secondary outcome
Plasma concentration of MT-1303 and its metabolite
Time frame: up to day 28
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 20 Feb 2015.
Related trials for Relapsing-remitting Multiple Sclerosis
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingObservational study
REAL-MS: Observational Database Study of AHSCT and MS Therapies
Multiple Sclerosis, Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 2
The HIt HArd and hiT Early in Multiple Sclerosis Trial
Relapsing-remitting Multiple Sclerosis
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.
Peter Sowood, M.D study director
Mitsubishi Tanabe Pharma Europe 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 MT-1303-Low, MT-1303-High and Fingolimod 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 8 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 20 Feb 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. Some participants in this study may receive a placebo. 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?
Mean hourly heart rate (time frame: up to day 42). 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 20 Feb 2015.