NCT01666327

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

2.1 years

First QC Date

August 8, 2012

Last Update Submit

September 4, 2014

Conditions

Inflammatory Bowel Disease

Keywords

Crohn's DiseaseUlcerative Colitis

Outcome Measures

Primary Outcomes (3)

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

    1month

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

    15 time points up to 1 month

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

    15 time points up to 1 month

Secondary Outcomes (3)

  • Pharmacodynamic effect of MT-1303 on lymphocyte count

    16 time points up to 1 month

  • Exploratory parameter : C-reactive protein (CRP)

    4 time points up to 1 week

  • Exploratory parameter :Erythrocyte sedimentation (ESR)

    4 time points up to 1 week

Study Arms (1)

MT-1303

EXPERIMENTAL
Drug: MT-1303

Interventions

MT-1303DRUG
MT-1303

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Interventions

amiselimod

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

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

August 8, 2012

First Posted

August 16, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations

GB(1)