Back to resultsA Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
Primary Purpose
Relapsing-remitting Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
MT-1303-Low
MT-1303-High
Fingolimod
Placebo
Sponsored by
About this trial
This is an interventional trial for Relapsing-remitting Multiple Sclerosis
Eligibility Criteria
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.
Sites / Locations
- Investigational site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
MT-1303-Low
MT-1303-High
Fingolimod
Placebo
Arm Description
MT-1303-Low dose
MT-1303-High dose
Fingolimod
Placebo
Outcomes
Primary Outcome Measures
Mean hourly heart rate
Secondary Outcome Measures
Plasma concentration of MT-1303 and its metabolite
Full Information
NCT ID
NCT02193217
First Posted
July 15, 2014
Last Updated
February 19, 2015
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02193217
Brief Title
A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis
7. Study Design
Study Phase
Phase 1
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MT-1303-Low
Arm Type
Experimental
Arm Description
MT-1303-Low dose
Arm Title
MT-1303-High
Arm Type
Experimental
Arm Description
MT-1303-High dose
Arm Title
Fingolimod
Arm Type
Active Comparator
Arm Description
Fingolimod
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
MT-1303-Low
Intervention Type
Drug
Intervention Name(s)
MT-1303-High
Intervention Type
Drug
Intervention Name(s)
Fingolimod
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean hourly heart rate
Time Frame
up to day 42
Secondary Outcome Measure Information:
Title
Plasma concentration of MT-1303 and its metabolite
Time Frame
up to day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Sowood, M.D
Organizational Affiliation
Mitsubishi Tanabe Pharma Europe Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
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