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Completed

NCT Number: NCT01666327

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

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.

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Key information

Conditions

Inflammatory Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Nottingham, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

MT-1303

Drug

Primary outcomes

  1. Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events

    Time frame: 1month

  2. Peak plasma concentration (Cmax) of MT-1303 and its metabolite

    Time frame: 15 time points up to 1 month

  3. Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite

    Time frame: 15 time points up to 1 month

Secondary outcomes

  1. Pharmacodynamic effect of MT-1303 on lymphocyte count

    Time frame: 16 time points up to 1 month

  2. Exploratory parameter : C-reactive protein (CRP)

    Time frame: 4 time points up to 1 week

  3. Exploratory parameter :Erythrocyte sedimentation (ESR)

    Time frame: 4 time points up to 1 week

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 16, 2012
Registry last updated
Sep 5, 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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