Comparative Oral Bioavailability Study of MT-1303

Relapsing-remitting Multiple Sclerosis Clinical Trial

Official title:

A Randomised, Open-Label, Single-Dose, Parallel Group Study to Assess the Comparative Oral Bioavailability of Two Capsule Formulations of MT-1303 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310048
• Other study ID #: MT-1303-E09
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2014
• Last updated: March 13, 2015
• Start date: November 2014
• Est. completion date: March 2015

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 assess the comparative oral bioavailability of a Formulation B versus the Formulation A of MT-1303.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel 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-FormA

• MT-1303-FormB

Locations

Country	Name	City	State
United Kingdom	Investigational site	Leeds

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	Area under the concentration-time curve(AUC) .		up to 6 weeks	No
Secondary	Peak drug concentration (Cmax) of MT-1303		up to 6 weeks	No
Secondary	Time to reach peak concentration (Tmax) of MT-1303		up to 6 weeks	No
Secondary	Half-life(t1/2.) of MT-1303		up to 6 weeks	No