Mass Balance Study of MT-1303

Sponsor

Mitsubishi Tanabe Pharma Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT02293967

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Relapsing-remitting Multiple Sclerosis	Drug: MT-1303	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MT-1303 [14C] MT-1303 after a single oral dose	Drug: MT-1303

Arm

Intervention/Treatment

Experimental: MT-1303

[14C] MT-1303 after a single oral dose

Drug: MT-1303

Outcome Measures

Primary Outcome Measures

Total radioactivity in urine and faeces [up to 10 weeks]

Secondary Outcome Measures

PK of total radioactivity in plasma [up to 10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Caucasian male aged 30 to 65 at Screening.
Body weight of ≥60 kg, and a BMI ranging from 18.0 to 32.0 kg/m2 at Screening and Day -1.
Normal or not clinically significant ECG as defined by a HR between 50 and 100 bpm inclusive at Screening, Day -1 and pre-dose.
Vital signs within the following ranges at Screening and Day -1,Body temperature: 35.0 to 37.5 °C,SBP: 90 to 140 mmHg,DBP: 50 to 90 mmHg.
Regular daily bowel movements.

Exclusion Criteria:

Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
Previous medical history of tuberculosis, or in the opinion of the Investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. The investigator should be guided by evidence of any of the following:
history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding;
history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational site	Ruddington	Nottingham	United Kingdom

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

Principal Investigator: Pui Leung, Quotient Clinical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mitsubishi Tanabe Pharma Corporation

ClinicalTrials.gov Identifier:

NCT02293967

Other Study ID Numbers:

MT-1303-E11

First Posted:

Nov 19, 2014

Last Update Posted:

Mar 17, 2015

Last Verified:

Mar 1, 2015

Additional relevant MeSH terms:

Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Study Results

No Results Posted as of Mar 17, 2015