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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01666327
First received: August 8, 2012
Last updated: September 4, 2014
Last verified: September 2014
  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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666327

Locations
United Kingdom
Research Site
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: September 4, 2014
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:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on September 29, 2014