Comparative Oral Bioavailability Study of MT-1303
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
What it found
We found no results in the registry or in papers.
This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- MT-1303-FormA
- MT-1303-FormB
What it measured
Main measures
Area under the concentration-time curve(AUC) .
up to 6 weeks
How the body handles the medicine
Other measures (3)
Peak drug concentration (Cmax) of MT-1303
up to 6 weeks
How the body handles the medicineTime to reach peak concentration (Tmax) of MT-1303
up to 6 weeks
Half-life(t1/2.) of MT-1303
up to 6 weeks
MRI lesionsHow the body handles the medicine
Who could take part
Relapsing MS · 18 to 55
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to assess the comparative oral bioavailability of a Formulation B versus the Formulation A of MT-1303.
Papers
Loading reviews and guidelines…
Related trials
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dime
Phase 3 · Not yet recruiting
Still running
- Study to Assess Effects of Ublituximab in Pediatric Participants With
Phase 2 / Phase 3 · Recruiting
Still running
- Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to
Phase 3 · Recruiting
Still running
- Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozani
Phase 4 · Recruiting
Still running
- Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarker
Phase 4 · Withdrawn
Stopped
- A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese
Phase 4 · Running, not recruiting
Still running
History
Started
Nov 2014
Main results due
Mar 2015
Finished
Mar 2015