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

Phase 1

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Drug: MT-1303

• Registration Number: NCT01666327
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-16
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MT-1303	MT-1303	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite	15 time points up to 1 month
Peak plasma concentration (Cmax) of MT-1303 and its metabolite	15 time points up to 1 month
Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events	1month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Nottingham, United Kingdom