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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

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