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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02148185

Enrollment

Registered

2014-05-28

Start date

2014-05-31

Completion date

2014-06-30

Last updated

2014-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's disease

Brief 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).

Interventions

DRUGMT-1303

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Change from baseline in lymphocyte count after MT-1303 administration	16 time points up to 29 days
Type of adverse events	29 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026