NCT02148185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

1 month

First QC Date

May 20, 2014

Last Update Submit

September 10, 2014

Conditions

Crohn's Disease

Keywords

Crohn's disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Change from baseline in lymphocyte count after MT-1303 administration

    16 time points up to 29 days

  • Type of adverse events

    29 days

Study Arms (1)

MT-1303

EXPERIMENTAL
Drug: MT-1303

Interventions

MT-1303DRUG
MT-1303

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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"

You may not qualify if:

  • Present or past history of gastrointestinal surgery which may have impact on drug absorption
  • Subjects with stenosis or fistula in small intestine or colon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Inverstigational site

Chūbu, Japan

Location

Inverstigational site

Kanto, Japan

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

amiselimod

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Mamoru Watanabe, MD

    Tokyo Medical and Dental University

    STUDY DIRECTOR

  • Kazuoki Kondo, MD

    Tanabe Pharma Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 28, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

JP(2)