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

Study Overview
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Brief Summary
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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
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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).

Official Title
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An Open-Label Study to Evaluate the Safety, Tolerability, Pharmacodynamics of a Single Oral Dose of MT-1303 in Subjects With Inflammatory Bowel Disease.

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: MT-1303


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-1303<br> | Drug: MT-1303<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events |  | 1month | 
| Peak plasma concentration (Cmax) of MT-1303 and its metabolite |  | 15 time points up to 1 month | 
| Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite |  | 15 time points up to 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Ulcerative Colitis