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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Fingolimod Hydrochloride

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.