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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 March 2015 |
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Main ID: |
NCT02193217 |
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Date of registration:
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15/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
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Scientific title:
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Date of first enrolment:
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September 2014 |
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Target sample size:
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81 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02193217 |
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Study type:
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Interventional |
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Study design:
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N/A
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Peter Sowood, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mitsubishi Tanabe Pharma Europe Ltd. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Relapsing-remitting Multiple Sclerosis
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Intervention(s)
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Drug: MT-1303-High
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Drug: MT-1303-Low
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Drug: Fingolimod
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Drug: Placebo
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Primary Outcome(s)
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Mean hourly heart rate
[Time Frame: up to day 42]
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Secondary Outcome(s)
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Plasma concentration of MT-1303 and its metabolite
[Time Frame: up to day 28]
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Secondary ID(s)
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MT-1303-E12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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