NCT02148185

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	MT-1303

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-05-28
• Last updated: 2014-09-12

Locations

2 sites across 1 country: Japan