A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Drug: MT-1303-High; Drug: Fingolimod; Drug: Placebo; Drug: MT-1303-Low

Study type: Interventional

Funder types: Industry

Identifiers

NCT02193217

MT-1303-E12

Details and patient eligibility

About

The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.

Enrollment: 81 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

81 participants in 4 patient groups, including a placebo group

MT-1303-Low

Experimental group

Description:

MT-1303-Low dose

Treatment:

Drug: MT-1303-Low

MT-1303-High

Experimental group

Description:

MT-1303-High dose

Treatment:

Drug: MT-1303-High

Fingolimod

Active Comparator group

Description:

Fingolimod

Treatment:

Drug: Fingolimod

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo