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Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects

NCT02136888 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2014-05-13

No results posted yet for this study

Summary

The aim of this study is to demonstrate that therapeutic and supratherapeutic plasma exposures to ponesimod do not have an effect on cardiac repolarization exceeding the threshold of regulatory concern as measured by the QTc (interval from beginning of the Q wave until end of the T wave corrected for heart rate) interval duration after administration of multiple oral doses of 40 mg and 100 mg to healthy male and female subjects.

Conditions

  • Healthy

Interventions

DRUG

Ponesimod Placebo

DRUG

Moxifloxacin Placebo

DRUG

Ponesimod 10 mg

DRUG

Ponesimod 20 mg

DRUG

Ponesimod 40 mg

DRUG

Ponesimod 60 mg

DRUG

Ponesimod 80 mg

DRUG

Ponesimod 100 mg

DRUG

Moxifloxacin 400 mg

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Patrick Brossard, PhD · Actelion

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02136888 on ClinicalTrials.gov