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Completed

NCT Number: NCT02148185

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inverstigational site, Chūbu, Japan

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-1303

Drug

Primary outcomes

  1. Plasma concentration of MT-1303

    Time frame: 15 time points up to 29 days

  2. Plasma concentration of MT-1303 metabolite

    Time frame: 15 time points up to 29 days

Secondary outcomes

  1. Change from baseline in lymphocyte count after MT-1303 administration

    Time frame: 16 time points up to 29 days

  2. Type of adverse events

    Time frame: 29 days

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 28, 2014
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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