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Comparative Oral Bioavailability Study of MT-1303

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ClinicalTrials.gov Identifier: NCT02310048
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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.

Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: MT-1303-FormA Drug: MT-1303-FormB Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MT-1303-FormA
MT-1303, Capsule Formulation A
Drug: MT-1303-FormA
Experimental: MT-1303-FormB
MT-1303, Capsule Formulation B
Drug: MT-1303-FormB



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

Secondary Outcome Measures :
  1. Peak drug concentration (Cmax) of MT-1303 [ Time Frame: up to 6 weeks ]
  2. Time to reach peak concentration (Tmax) of MT-1303 [ Time Frame: up to 6 weeks ]
  3. Half-life(t1/2.) of MT-1303 [ Time Frame: up to 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310048


Locations
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United Kingdom
Investigational site
Leeds, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Principal Investigator: Jim Bush, Dr. Covance CRU Ltd.
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02310048    
Other Study ID Numbers: MT-1303-E09
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases