Cardiac Effects of MT-1303, Placebo and Fingolimod

• Research type

  Research Study

• Full title

  A Randomised, Parallel-group, Partially-blinded, Placebo controlled Study to Explore the Cardiac Pharmacodynamics, Safety and Tolerability of Multiple Doses of MT-1303 Compared to Placebo and Fingolimod in Healthy Subjects

• IRAS ID

  154855

• Sponsor organisation

  Mitsubishi Tanabe Pharma Europe Ltd

• Eudract number

  2014-001520-29

• Research summary

  The Study Drug is an investigational drug being developed with the aim of helping people with inflammatory and auto-immune disorders such as multiple sclerosis, psoriasis, inflammatory bowel disease and systemic lupus erythematosus. In diseases like these lymphocytes (a type of white blood cell) are released from the lymphoid tissues (bone marrow, lymph nodes and spleen), where they develop, into the lymphatic circulation and bloodstream. They then travel towards different areas of the body (e.g. skin, brain, joints and gut) where they cause inflammation. This leads to symptoms of the disease.

  A mediator called Sphingosine-1-Phosphate (S1P) is involved in the release of lymphocytes into the circulation through an interaction with the S1P1 receptor which is found on the surface of cells within lymphoid tissues. The Study Drug is an S1P receptor modulator; it is hoped that Study Drug will work by blocking the action of S1P at the S1P1 receptor to prevent the release of lymphocytes.

  One S1P receptor modulator called fingolimod has been approved and is already used to treat patients with Multiple Sclerosis. Fingolimod is also active at other S1P receptors at which the Study Drug is not active. Fingolimod causes some temporary effects on the heart. The most common of these is a decrease in heart rate. Rarely the decreased heart rate is associated with a delay in the passage of electric impulses through the heart which occasionally causes the heart to miss beats. These delays are predominately seen following the first dose of the drug and at higher dose levels.

  The Study Drug was designed to have fewer adverse effects than fingolimod. The purpose of this study is to investigate the effects of the Study Drug on the heart and to compare with the effects of fingolimod.

• REC name

  North East - York Research Ethics Committee

• REC reference

  14/NE/0139

• Date of REC Opinion

  14 Jul 2014

• REC opinion

  Further Information Favourable Opinion