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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01666327

Enrollment

Registered

2012-08-16

Start date

2012-06-30

Completion date

2014-07-31

Last updated

2014-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

Crohn's Disease, Ulcerative Colitis

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).

Interventions

DRUGMT-1303

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	Time frame
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
Pharmacodynamic effect of MT-1303 on lymphocyte count	16 time points up to 1 month

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026