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

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666327
• Other study ID #: MT-1303-E03
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2012
• Last updated: September 4, 2014
• Start date: June 2012
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• MT-1303

Locations

Country	Name	City	State
United Kingdom	Research Site	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events		1month	Yes
Primary	Peak plasma concentration (Cmax) of MT-1303 and its metabolite		15 time points up to 1 month	No
Primary	Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite		15 time points up to 1 month	No
Secondary	Pharmacodynamic effect of MT-1303 on lymphocyte count		16 time points up to 1 month	No
Secondary	Exploratory parameter : C-reactive protein (CRP)		4 time points up to 1 week	No
Secondary	Exploratory parameter :Erythrocyte sedimentation (ESR)		4 time points up to 1 week	No