Bioavailability Study of Two Capsule Formulations of MT-1303
Research type
Research Study
Full title
A Randomised, Open-Label, Single-Dose, Parallel Group Study to Assess the Comparative Oral Bioavailability of Two Capsule Formulations of MT-1303 in Healthy Male Subjects
IRAS ID
161313
Contact name
Jim Bush
Contact email
Sponsor organisation
Mitsubishi Tanabe Pharma Europe Ltd
Eudract number
2014-001669-29
Research summary
The study drug is an investigational drug being developed with the aim of helping people with inflammatory and autoimmune 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.This is a clinical pharmacology study where healthy male subjects will receive single oral doses of MT-1303 as either Formulation A (current formulation) or Formulation B (new formulation). There will be no expectation of health benefits for subjects; however, the data from this study will be used to support future clinical studies in which subjects may obtain a health benefit.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
14/SC/1242
Date of REC Opinion
3 Oct 2014
REC opinion
Favourable Opinion