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

Tanabe Pharma Corporation1 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn's Disease

Interventions

MT-1303DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Inverstigational site

Chūbu, Japan

Inverstigational site

Kanto, Japan

Outcomes

Primary Outcomes

Plasma concentration of MT-1303

Time frame: 15 time points up to 29 days

Plasma concentration of MT-1303 metabolite

Time frame: 15 time points up to 29 days

Secondary Outcomes

Change from baseline in lymphocyte count after MT-1303 administration

Time frame: 16 time points up to 29 days

Type of adverse events

Time frame: 29 days

Data from ClinicalTrials.gov

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