Status:
COMPLETED
A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Relapsing-remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT02193217
End Date
January 1 2015
Last Update
February 20 2015
Active Locations (1)
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1
Investigational site
Leeds, United Kingdom