Comparative Oral Bioavailability Study of MT-1303

• Register: ClinicalTrials.gov
• Last refreshed on: 23 March 2015
• Main ID: NCT02310048
• Date of registration: 14/11/2014
• Prospective Registration: No
• Primary sponsor: Mitsubishi Tanabe Pharma Corporation
• Public title: Comparative Oral Bioavailability Study of MT-1303
• Scientific 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
• Date of first enrolment: November 2014
• Target sample size: 34
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02310048
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Jim Bush, Dr.
• Affiliation: Covance CRU Ltd.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Relapsing-remitting Multiple Sclerosis

Intervention(s)

Drug: MT-1303-FormA

Drug: MT-1303-FormB

Primary Outcome(s)

Area under the concentration-time curve(AUC) . [Time Frame: up to 6 weeks]

Secondary Outcome(s)

Peak drug concentration (Cmax) of MT-1303 [Time Frame: up to 6 weeks]

Half-life(t1/2.) of MT-1303 [Time Frame: up to 6 weeks]

Time to reach peak concentration (Tmax) of MT-1303 [Time Frame: up to 6 weeks]

Secondary ID(s)

MT-1303-E09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors