A phase 1 study of MT-1303 in healthy subjects

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo-controlled, first-time-in-human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of MT-1303 in healthy subjects

• IRAS ID

  63728

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Mitsubishi Tanabe Pharma Corporation (MTPC)

• Eudract number

  2010-021831-14

• ISRCTN Number

  1

• Research summary

  The drug being tested in this study is called MT-1303 and it’s being developed for the treatment of Multiple Sclerosis. MT-1303 has not been tested in humans before. The purpose of this study is to investigate the safety and tolerability of MT-1303. This study will be conducted in a total of 80 volunteers. Each volunteer will be given a single dose of the drug and will be followed up for at least 50 days. This study will be conducted in 3 parts:* Part 1: single dose study in 7 groups of 10 subjects. Each subject will receive a single oral dose of MT-1303 or placebo before food (fasted). The dose of MT-1303 will increase with each successive group. * Part 2: single dose food effect study in one group form Part 1 (10 subjects). Each subject will return for a single oral dose of MT-1303 or placebo after a high fat breakfast (fed). * Part 3: single dose study in one group of 10 female subjects to examine any differences in the effects of MT-1303 between male and female subjects. Each subject will receive a single oral dose of MT-1303 or placebo in the fasted state. This is a “blind” study therefore neither the subject nor clinical staff will know the treatment allocation. Safety assessments will be performed on each subject throughout the study. These will include physical examinations, measurements of blood pressure, pulse, temperature, 12-lead ECG and lung function. Monitoring of any new signs or symptoms will be continuous. Blood and urine samples will be collected for laboratory safety tests and to measure the levels of the drug, its breakdown products and effects on the body. The safety and welfare of the volunteers have been fully considered and will continue to be paramount during the course of the research study.

• REC name

  Wales REC 2

• REC reference

  10/WSE02/60

• Date of REC Opinion

  15 Oct 2010

• REC opinion

  Favourable Opinion