Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease
Phase 1
Completed
- Conditions
- Crohn's Disease
- Interventions
- Drug: MT-1303
- Registration Number
- NCT02148185
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303 in subjects with Crohn's disease.
- Detailed Description
This is a Phase I, open-label, non-randomised, multicenter single-dose study to evaluate PK, PD, and safety of a single oral dose of MT-1303 in subjects with moderate to severe active Crohn's disease (ileal and ileo-colonic type).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
- Subjects who were diagnosed as Crohn's disease
- Subjects who were confirmed as ileal or ileo-colonic type by image inspection.
- Disease severity determined as either "moderate" or "severe"
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Exclusion Criteria
- Present or past history of gastrointestinal surgery which may have impact on drug absorption
- Subjects with stenosis or fistula in small intestine or colon
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MT-1303 MT-1303 -
- Primary Outcome Measures
Name Time Method Plasma concentration of MT-1303 15 time points up to 29 days Plasma concentration of MT-1303 metabolite 15 time points up to 29 days
- Secondary Outcome Measures
Name Time Method Change from baseline in lymphocyte count after MT-1303 administration 16 time points up to 29 days Type of adverse events 29 days
Trial Locations
- Locations (1)
Inverstigational site
🇯🇵Kanto, Japan