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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Crohn's Disease

Treatments: Drug: MT-1303

Study type: Interventional

Funder types: Industry

Identifiers

NCT02148185

MT-1303-J02

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 1 patient

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

MT-1303

Experimental group

Treatment:

Drug: MT-1303