Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease

A Phase I, Open-label Study to Evaluate PK, PD, and Safety of a Single Oral Dose of MT-1303 in Subjects With Moderate to Severe Crohn's Disease

The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303 in subjects with Crohn's disease.

This is a Phase I, open-label, non-randomised, multicenter single-dose study to evaluate PK, PD, and safety of a single oral dose of MT-1303 in subjects with moderate to severe active Crohn's disease (ileal and ileo-colonic type).

Inclusion Criteria:

• Subjects who were diagnosed as Crohn's disease
• Subjects who were confirmed as ileal or ileo-colonic type by image inspection.
• Disease severity determined as either "moderate" or "severe"

Exclusion Criteria:

• Present or past history of gastrointestinal surgery which may have impact on drug absorption
• Subjects with stenosis or fistula in small intestine or colon