Relapsing-remitting Multiple Sclerosis
Conditions
Brief summary
The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.
Interventions
Sponsors
Tanabe Pharma Corporation
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean hourly heart rate | up to day 42 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration of MT-1303 and its metabolite | up to day 28 |
Countries
United Kingdom
Outcome results
None listed