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

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02193217
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arms: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Relapsing-remitting Multiple Sclerosis	Drug: MT-1303-Low; Drug: MT-1303-High; Drug: Fingolimod; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MT-1303-Low MT-1303-Low dose	Drug: MT-1303-Low
Experimental: MT-1303-High MT-1303-High dose	Drug: MT-1303-High
Active Comparator: Fingolimod Fingolimod	Drug: Fingolimod
Placebo Comparator: Placebo Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Mean hourly heart rate [up to day 42]

Secondary Outcome Measures

1. Plasma concentration of MT-1303 and its metabolite [up to day 28]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational site	Leeds		United Kingdom

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

• Study Director: Peter Sowood, M.D, Mitsubishi Tanabe Pharma Europe Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT02193217
• Other Study ID Numbers: MT-1303-E12
• First Posted: Jul 17, 2014
• Last Update Posted: Feb 20, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Fingolimod Hydrochloride

Study Results

No Results Posted as of Feb 20, 2015