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

February 19, 2015 updated by: Mitsubishi Tanabe Pharma Corporation
The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
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
Drug: Fingolimod

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean hourly heart rate
Time Frame: up to day 42
up to day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of MT-1303 and its metabolite
Time Frame: up to day 28
up to day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Estimate)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-1303-E12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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