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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02148185

Crohn's Disease

COMPLETED PHASE1

Safety and Efficacy of MT-1303 in Subjects With Moderate to Severe Active Crohn's Disease

NCT02378688

Crohn's Disease

COMPLETED PHASE2

Extension Study of MT-1303 in Subjects With Crohn's Disease

NCT02389790

Crohn's Disease

COMPLETED PHASE2

A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

NCT07113522

Inflammatory Bowel Disease (IBD) Ulcerative Colitis (UC) Crohn's Disease

RECRUITING PHASE2

Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis

NCT04857112

Ulcerative Colitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MT-1303

Group Type EXPERIMENTAL

MT-1303

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MT-1303

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No