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Completed

NCT Number: NCT02193217

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

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

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational site

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MT-1303-Low

Drug

MT-1303-High

Drug

Fingolimod

Drug

Placebo

Drug

Primary outcomes

  1. Mean hourly heart rate

    Time frame: up to day 42

Secondary outcomes

  1. Plasma concentration of MT-1303 and its metabolite

    Time frame: up to day 28

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Important dates

Primary completion
2014
Study completion
2015
First posted
Jul 17, 2014
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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