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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Inflammatory Bowel Disease

Treatments: Drug: MT-1303

Study type: Interventional

Funder types: Industry

Identifiers

NCT01666327

MT-1303-E03

Details and patient eligibility

About

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.

Full description

This is an open-label, non-randomised, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MT-1303 in subjects with inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis).

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

MT-1303

Experimental group

Treatment:

Drug: MT-1303