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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:
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

August 8, 2012
September 4, 2014
June 2012
July 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01666327 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease
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.

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).

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Inflammatory Bowel Disease
Drug: MT-1303
Experimental: MT-1303
Intervention: Drug: MT-1303
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01666327
MT-1303-E03
Not Provided
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP