NCT02193217

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

First QC Date

July 15, 2014

Last Update Submit

February 19, 2015

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Mean hourly heart rate

    up to day 42

Secondary Outcomes (1)

  • Plasma concentration of MT-1303 and its metabolite

    up to day 28

Study Arms (4)

MT-1303-Low

EXPERIMENTAL

MT-1303-Low dose

Drug: MT-1303-Low

MT-1303-High

EXPERIMENTAL

MT-1303-High dose

Drug: MT-1303-High

Fingolimod

ACTIVE COMPARATOR

Fingolimod

Drug: Fingolimod

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MT-1303-LowDRUG
MT-1303-Low
MT-1303-HighDRUG
MT-1303-High
FingolimodDRUG
Fingolimod
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational site

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Study Officials

  • Peter Sowood, M.D

    Mitsubishi Tanabe Pharma Europe Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 17, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

February 20, 2015

Record last verified: 2015-02

Locations

GB(1)