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

September 4, 2014 updated by: Mitsubishi Tanabe Pharma Corporation

An Open-Label Study to Evaluate the Safety, Tolerability, Pharmacodynamics of a Single Oral Dose of MT-1303 in Subjects With Inflammatory Bowel Disease.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MT-1303
Drug: MT-1303

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events
Time Frame: 1month
1month
Peak plasma concentration (Cmax) of MT-1303 and its metabolite
Time Frame: 15 time points up to 1 month
15 time points up to 1 month
Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite
Time Frame: 15 time points up to 1 month
15 time points up to 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic effect of MT-1303 on lymphocyte count
Time Frame: 16 time points up to 1 month
16 time points up to 1 month
Exploratory parameter : C-reactive protein (CRP)
Time Frame: 4 time points up to 1 week
4 time points up to 1 week
Exploratory parameter :Erythrocyte sedimentation (ESR)
Time Frame: 4 time points up to 1 week
4 time points up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 10, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-1303-E03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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