Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-1303 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-1303 | Drug |
|
| 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 |
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nottingham | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000624397 | amiselimod |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Exploratory parameter :Erythrocyte sedimentation (ESR) |
| 4 time points up to 1 week |
| D003092 | Colitis |
| D003108 | Colonic Diseases |