Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety S... | NCT02148185

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

NCT02148185

Sponsor

Tanabe Pharma Corporation

Status

Completed

Last Update Posted

Sep 12, 2014Estimated

Enrollment

1Actual

Phase

Phase 1

Conditions

Crohn's Disease

Interventions

MT-1303

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

May 20, 2014

First Submission Date that Met QC Criteria

May 27, 2014

First Posted Date

May 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2014

Last Update Posted Date

Sep 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Label	Type	Description	Intervention Names
MT-1303	Experimental		Drug: MT-1303

Name	Type	Description	Arm Group Labels	Other Names
MT-1303	Drug		MT-1303

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mamoru Watanabe, MD	Tokyo Medical and Dental University	Study Director
Kazuoki Kondo, MD	Tanabe Pharma Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inverstigational site		Chūbu			Japan
Inverstigational site

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000624397	amiselimod

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided