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

This study is currently recruiting participants.
Verified February 2013 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01666327
First received: August 8, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • Peak plasma concentration (Cmax) of MT-1303 and its metabolite [ Time Frame: 15 time points up to 1 month ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite [ Time Frame: 15 time points up to 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic effect of MT-1303 on lymphocyte count [ Time Frame: 16 time points up to 1 month ] [ Designated as safety issue: No ]
  • Exploratory parameter : C-reactive protein (CRP) [ Time Frame: 4 time points up to 1 week ] [ Designated as safety issue: No ]
  • Exploratory parameter :Erythrocyte sedimentation (ESR) [ Time Frame: 4 time points up to 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666327

Contacts
Contact: Clinical Trials INformation Desk cti-inq-ml@ml.mt-pharma.co.jp

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

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01666327     History of Changes
Other Study ID Numbers: MT-1303-E03
Study First Received: August 8, 2012
Last Updated: February 27, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on May 23, 2013