An Open-Label Study to Evaluate the Safety, Tolerability, Pharmacodynamics of a Single Oral Dose of MT-1303 in Subjects With Inflammatory Bowel Disease.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
MT-1303
Intervention: MT-1303 (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite
Time Frame: 15 time points up to 1 month
Peak plasma concentration (Cmax) of MT-1303 and its metabolite
Time Frame: 15 time points up to 1 month
Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events
Time Frame: 1month
Secondary Outcomes
- Exploratory parameter : C-reactive protein (CRP)(4 time points up to 1 week)
- Pharmacodynamic effect of MT-1303 on lymphocyte count(16 time points up to 1 month)
- Exploratory parameter :Erythrocyte sedimentation (ESR)(4 time points up to 1 week)