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

Patrocinadores

Patrocinador principal: Mitsubishi Tanabe Pharma Corporation

Fuente Mitsubishi Tanabe Pharma Corporation
Resumen breve

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.

Descripción detallada

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).

Estado general Completed
Fecha de inicio May 2014
Fecha de Terminación June 2014
Fecha de finalización primaria June 2014
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Plasma concentration of MT-1303 15 time points up to 29 days
Plasma concentration of MT-1303 metabolite 15 time points up to 29 days
Resultado secundario
Medida Periodo de tiempo
Change from baseline in lymphocyte count after MT-1303 administration 16 time points up to 29 days
Type of adverse events 29 days
Inscripción 1
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: MT-1303

Etiqueta de grupo de brazo: MT-1303

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 20 Years

Edad máxima: 65 Years

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
Inverstigational site | Chubu, Japan
Inverstigational site | Kanto, Japan
Ubicacion Paises

Japan

Fecha de verificación

September 2014

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: MT-1303

Tipo: Experimental

Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov