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

Phase 1 Completed 116 enrolled Actelion

RandomizedParallel-groupTriple-blind

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.

Timeline

Start: 2011-08
Primary completion: 2012-02
Completion: 2012-02

Publications

Hoch M, Darpo B, Brossard P, Zhou M, Stoltz R, Dingemanse J. Effect of ponesimod, a selective S1P1 receptor modulator, on the QT interval in healthy individuals. Basic Clin Pharmacol Toxicol. 2015 May;116(5):429-37. doi: 10.1111/bcpt.12336. Epub 2014 Nov 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Moxifloxacin	Small molecule	400 mg	Oral
Subject	Ponesimod	Small molecule	100 mg	Oral

Indications

No indication recorded.