Back to resultsSafety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Disease
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
MT-1303
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Crohn's Disease, Ulcerative Colitis
Eligibility 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.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MT-1303
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events
Peak plasma concentration (Cmax) of MT-1303 and its metabolite
Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite
Secondary Outcome Measures
Pharmacodynamic effect of MT-1303 on lymphocyte count
Exploratory parameter : C-reactive protein (CRP)
Exploratory parameter :Erythrocyte sedimentation (ESR)
Full Information
NCT ID
NCT01666327
First Posted
August 8, 2012
Last Updated
September 4, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01666327
Brief Title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Crohn's Disease, Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MT-1303
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MT-1303
Primary Outcome Measure Information:
Title
Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events
Time Frame
1month
Title
Peak plasma concentration (Cmax) of MT-1303 and its metabolite
Time Frame
15 time points up to 1 month
Title
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 Measure Information:
Title
Pharmacodynamic effect of MT-1303 on lymphocyte count
Time Frame
16 time points up to 1 month
Title
Exploratory parameter : C-reactive protein (CRP)
Time Frame
4 time points up to 1 week
Title
Exploratory parameter :Erythrocyte sedimentation (ESR)
Time Frame
4 time points up to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Research Site
City
Nottingham
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease
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