A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to explore the cardiac pharmacodynamics, safety and tolerability of MT-1303 in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dose-finding Study of MT-1303

NCT01742052

Relapsing-remitting Multiple Sclerosis

COMPLETED PHASE2

Extension Study of MT-1303

NCT01890655

Relapsing-remitting Multiple Sclerosis

COMPLETED PHASE2

Comparative Oral Bioavailability Study of MT-1303

NCT02310048

Relapsing-remitting Multiple Sclerosis

COMPLETED PHASE1

Mass Balance Study of MT-1303

NCT02293967

Relapsing-remitting Multiple Sclerosis

COMPLETED PHASE1

Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

NCT01201356

Relapsing Forms of Multiple Sclerosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsing-remitting Multiple Sclerosis

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MT-1303-Low

MT-1303-Low dose

Group Type EXPERIMENTAL

MT-1303-Low

Intervention Type DRUG

MT-1303-High

MT-1303-High dose

Group Type EXPERIMENTAL

MT-1303-High

Intervention Type DRUG

Fingolimod

Group Type ACTIVE_COMPARATOR

Fingolimod

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MT-1303-Low

Intervention Type DRUG

MT-1303-High

Intervention Type DRUG

Fingolimod

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes