Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease.

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

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Criteria

Inclusion Criteria:

• A body mass index (BMI) ranging from 16 to 34 kg/m2

• Subjects who were diagnosed as Crohn's Disease or Ulcerative Colitis at least 6 months prior to Screening, clinically confirmed either by radiological, endoscopic or histological examination.

• Subjects who have had at least one flare within 18 months prior to Screening.

• Confirmed medical records of inflammatory lesions in intestinal tract

Exclusion Criteria:

• Present or past history of clinically significant gastrointestinal surgery.

• Present or past history of clinically significant stenosis, stricture or fistula in small intestine or colon.

• Known hypersensitivity to any formulation excipients.