Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety Study of MT-1303 in Subjects With Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

A Phase I, Open-label Study to Evaluate PK, PD, and Safety of a Single Oral Dose of MT-1303 in Subjects With Moderate to Severe Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148185
• Other study ID #: MT-1303-J02
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2014
• Last updated: September 10, 2014
• Start date: May 2014
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate PK, PD and safety of a single oral dose of MT-1303 in subjects with Crohn's disease.

Description:

This is a Phase I, open-label, non-randomised, multicenter single-dose study to evaluate PK, PD, and safety of a single oral dose of MT-1303 in subjects with moderate to severe active Crohn's disease (ileal and ileo-colonic type).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects who were diagnosed as Crohn's disease

• Subjects who were confirmed as ileal or ileo-colonic type by image inspection.

• Disease severity determined as either "moderate" or "severe"

Exclusion Criteria:

• Present or past history of gastrointestinal surgery which may have impact on drug absorption

• Subjects with stenosis or fistula in small intestine or colon

Study Design

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• MT-1303

Locations

Country	Name	City	State
Japan	Inverstigational site	Chubu
Japan	Inverstigational site	Kanto

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of MT-1303		15 time points up to 29 days	No
Primary	Plasma concentration of MT-1303 metabolite		15 time points up to 29 days	No
Secondary	Change from baseline in lymphocyte count after MT-1303 administration		16 time points up to 29 days	No
Secondary	Type of adverse events		29 days	Yes