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

Primary Purpose

Crohn's Disease

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

MT-1303

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Inverstigational site
Inverstigational site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MT-1303

Arm Description

Outcomes

Primary Outcome Measures

Plasma concentration of MT-1303

Plasma concentration of MT-1303 metabolite

Secondary Outcome Measures

Change from baseline in lymphocyte count after MT-1303 administration

Type of adverse events

Full Information

NCT ID

NCT02148185

First Posted

May 20, 2014

Last Updated

September 10, 2014

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02148185

Brief Title

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

Official Title

A Phase I, Open-label Study to Evaluate PK, PD, and Safety of a Single Oral Dose of MT-1303 in Subjects With Moderate to Severe Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Crohn's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MT-1303

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

MT-1303

Primary Outcome Measure Information:

Title

Plasma concentration of MT-1303

Time Frame

15 time points up to 29 days

Title

Plasma concentration of MT-1303 metabolite

Time Frame

15 time points up to 29 days

Secondary Outcome Measure Information:

Title

Change from baseline in lymphocyte count after MT-1303 administration

Time Frame

16 time points up to 29 days

Title

Type of adverse events

Time Frame

29 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mamoru Watanabe, MD

Organizational Affiliation

Tokyo Medical and Dental University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Kazuoki Kondo, MD

Organizational Affiliation

Mitsubishi Tanabe Pharma Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Inverstigational site

City

Chubu

Country

Japan

Facility Name

Inverstigational site

City

Kanto

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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