Comparative Oral Bioavailability Study of MT-1303

NCT02310048 | Completed Phase 1

• 1 other identifier: MT-1303-E09
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Area under the concentration-time curve(AUC) .

  up to 6 weeks

Secondary Outcomes (3)

• Peak drug concentration (Cmax) of MT-1303

  up to 6 weeks

• Time to reach peak concentration (Tmax) of MT-1303

  up to 6 weeks

• Half-life(t1/2.) of MT-1303

  up to 6 weeks

Study Arms (2)

MT-1303-FormA

EXPERIMENTAL

MT-1303, Capsule Formulation A

Drug: MT-1303-FormA

MT-1303-FormB

EXPERIMENTAL

MT-1303, Capsule Formulation B

Drug: MT-1303-FormB

Interventions

MT-1303-FormA DRUG

MT-1303-FormA

MT-1303-FormB DRUG

MT-1303-FormB

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational site

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jim Bush, Dr.

  Covance CRU Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: December 5, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

GB (1)