Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

MT-1303

Drug
Who is being recruted

Colitis+6

+ Colonic Diseases

+ Digestive System Diseases

From 18 to 65 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorTanabe Pharma Corporation
Last updated: September 5, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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).

NCT01666327
Principal SponsorTanabe Pharma Corporation
Last updated: September 5, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

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

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ColitisColonic DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesColitis, UlcerativeCrohn DiseaseInflammatory Bowel Diseases

Criteria

4 inclusion criteria required to participate
A body mass index (BMI) ranging from 16 to 34 kg/m2
Confirmed medical records of inflammatory lesions in intestinal tract
Subjects who have had at least one flare within 18 months prior to Screening
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
3 exclusion criteria prevent from participating
Known hypersensitivity to any formulation excipients
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Research Site

Nottingham, United KingdomOpen Research Site in Google Maps
CompletedOne Study Center