A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303
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
What it measured
Main measures
Mean hourly heart rate
up to day 42
Other measures (1)
Plasma concentration of MT-1303 and its metabolite
up to day 28
How the body handles the medicine
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
* Healthy and free from clinically significant illness or disease. * Male and female subjects of non-childbearing potential aged 18 to 55 years. * Normal or non-clinically significant 12-lead ECG. * Holter recording with no clinically significant abnormalities. * Systolic blood pressure: 90 to 140 mmHg, diastolic blood pressure: 50 to 90 mmHg
Exclusion criteria
* A History of severe adverse reaction or allergy to any medical product. * Clinically significant endocrine, thyroid, hepatic, respiratory, gastrointestinal, renal, cardiovascular disease, eye disorder or history of psychiatric/psychotic disorder. * A history of tuberculosis. * Have a positive HBsAg, HBcAb, HCVAb or HIV-1 and HIV-2 test. * Previously having received MT-1303, fingolimod, or any other sphingosine-1-phosphate receptor modulators. * Clinical relevant abnormal medical history, or physical findings or laboratory values. * Clinically significant 12-lead ECG abnormalities. * Clinical relevant abnormal findings in echocardiograph.
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 explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.
Papers
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History
Main results due
Dec 2014
Finished
Jan 2015