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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666327
First Posted: August 16, 2012
Last Update Posted: September 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  Purpose
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.

Condition Intervention Phase
Inflammatory Bowel Disease Drug: MT-1303 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Safety, Tolerability, Pharmacodynamics of a Single Oral Dose of MT-1303 in Subjects With Inflammatory Bowel Disease.

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events [ Time Frame: 1month ]
  • Peak plasma concentration (Cmax) of MT-1303 and its metabolite [ Time Frame: 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 ]

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

Enrollment: 18
Study Start Date: June 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MT-1303 Drug: MT-1303

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666327


Locations
United Kingdom
Research Site
Nottingham, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01666327     History of Changes
Other Study ID Numbers: MT-1303-E03
First Submitted: August 8, 2012
First Posted: August 16, 2012
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Crohn's Disease
Ulcerative Colitis

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis