Safety, tolerability, PK and PD of MT-1303 in IBD subjects (QBR112851)

• Research type

  Research Study

• Full title

  An open-label study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease of moderate-to-severe severity.

• IRAS ID

  102741

• Contact name

  Stuart Mair

• Sponsor organisation

  Mitsubishi Pharma Europe Ltd.

• Eudract number

  2012-000135-86

• Research summary

  The Sponsor is developing the study drug MT-1303, which has a more targeted action and may be more effective in the mitigation of Inflammatory Bowel Disease (IBD) than existing treatments. This study will assess the safety, tolerability, pharmacokinetics (PK) or how well the drug is taken up by the body, and the pharmacodynamics (PD) or how the drug acts on the body. Subjects will be moderate-to-severe IBD sufferers of either Crohn's Disease or Ulcerative Colitis. The first two subjects will have active Crohns and will receive a single oral dose of 0.125 mg MT-1303 on one occasion. If there are no safety concerns and after interim analysis an unexpectedly low concentration of the drug is found to be detectable, the following subjects may receive a higher dose up to 0.25 mg MT-1303.

• REC name

  HSC REC A

• REC reference

  12/NI/0048

• Date of REC Opinion

  5 Apr 2012

• REC opinion

  Further Information Favourable Opinion