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

Phase 1

Completed

• Conditions: Relapsing-remitting Multiple Sclerosis
• Interventions: Drug: MT-1303-Low; Drug: MT-1303-High; Drug: Placebo; Drug: Fingolimod

• Registration Number: NCT02193217
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-19
• Last Update Posted: 2015-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MT-1303-Low	MT-1303-Low	MT-1303-Low dose
MT-1303-High	MT-1303-High	MT-1303-High dose
Placebo	Placebo	Placebo
Fingolimod	Fingolimod	Fingolimod

Primary Outcome Measures

Name	Time	Method
Mean hourly heart rate	up to day 42

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of MT-1303 and its metabolite	up to day 28

Trial Locations

Locations (1)

Investigational site; 🇬🇧 Leeds, United Kingdom