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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Research Site
Nottingham, United Kingdom
Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events
Time frame: 1month
Peak plasma concentration (Cmax) of MT-1303 and its metabolite
Time frame: 15 time points up to 1 month
Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite
Time frame: 15 time points up to 1 month
Pharmacodynamic effect of MT-1303 on lymphocyte count
Time frame: 16 time points up to 1 month
Exploratory parameter : C-reactive protein (CRP)
Time frame: 4 time points up to 1 week
Exploratory parameter :Erythrocyte sedimentation (ESR)
Time frame: 4 time points up to 1 week
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