Comparative Oral Bioavailability Study of MT-1303

NCT ID: NCT02310048

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-03-31

Brief Summary

The purpose of this study is to assess the comparative oral bioavailability of a Formulation B versus the Formulation A of MT-1303.

Conditions

Relapsing-remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MT-1303-FormA

MT-1303, Capsule Formulation A

Group Type: EXPERIMENTAL

MT-1303-FormA

Intervention Type: DRUG

MT-1303-FormB

MT-1303, Capsule Formulation B

Group Type: EXPERIMENTAL

MT-1303-FormB

Intervention Type: DRUG

Interventions

MT-1303-FormA

Intervention Type: DRUG

MT-1303-FormB

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Caucasian males aged 18 to 55 years at Screening.
• Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory, and other tests at Screening and Day -1.
• A body weight of ≥60 kilograms (kg) and BMI ranging from 18 to 30 kg/m2 at Screening or Day -1.

Exclusion Criteria

• Presence or history of severe adverse reaction or allergy to any medicinal product or relevant excipient that is of clinical significance.
• Participated in more than three clinical studies of a new chemical entity in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives of the IMP before the administration of the IMP in this clinical study.
• Clinically relevant abnormal medical history, physical findings, or laboratory values at Screening or Day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator.
• 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 infection.
• Subjects who have received any prescribed systemic or topical medication within 14 days prior to administration of the IMP(Day 1) unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety. Slow release medicinal formulations considered to still be active within 14 days prior to the first dose administration will also be excluded unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jim Bush, Dr.

Role: PRINCIPAL_INVESTIGATOR

Covance CRU Ltd.

Locations

Investigational site

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

MT-1303-E09

Identifier Type: -

Identifier Source: org_study_id