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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Crohn's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MT-1303

Group Type EXPERIMENTAL

MT-1303

Intervention Type DRUG

Interventions

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MT-1303

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No