Mass Balance Study of MT-1303

Relapsing-remitting Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293967
• Other study ID #: MT-1303-E11
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2014
• Last updated: March 13, 2015
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis

Intervention

Drug:
• MT-1303

Locations

Country	Name	City	State
United Kingdom	Investigational site	Ruddington	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radioactivity in urine and faeces		up to 10 weeks	No
Secondary	PK of total radioactivity in plasma		up to 10 weeks	No