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Completed

NCT Number: NCT02310048

Comparative Oral Bioavailability Study of MT-1303

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MT-1303-FormA

Drug

MT-1303-FormB

Drug

Primary outcomes

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

    Time frame: up to 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2014
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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