NCT02136888

A Single-center, Double-blind, Randomized, Placebo- and Positive-controlled, Parallel-group, Multiple-dose, Up-titration Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects

Completed Phase 1 Last updated 12 May 2014

What this trial tests

Phase 1 trial testing Ponesimod Placebo in Healthy in 116 participants. Completed in 1 February 2012.

Timeline

1 August 2011

Primary endpoint
1 February 2012

1 February 2012

Quick facts

Lead sponsor	Actelion
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Enrollment	116
Start date	1 August 2011
Primary completion	1 February 2012
Estimated completion	1 February 2012
Sites	1 location across United States

Drugs / interventions tested

• Ponesimod Placebo
• Moxifloxacin Placebo — full drug profile →
• Ponesimod 10 mg
• Ponesimod 20 mg
• Ponesimod 40 mg — full drug profile →
• Ponesimod 60 mg — full drug profile →
• Ponesimod 80 mg — full drug profile →
• Ponesimod 100 mg — full drug profile →
• Moxifloxacin 400 mg

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Actelion — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Baseline-adjusted, placebo-corrected effect on QTc interval (time interval from beginning of the Q wave until end of the T wave (ΔΔQTc interval)) on Day 12 (after 5 days of 40 mg ponesimod)
  Time frame: 12 Days
  Replicate electrocardiograms (ECGs) (at least 3 and up to 10) for the determination of ΔΔQTc interval will be extracted from the continuous digital 12-lead ECG recording within 20 minutes prior to dosing and then at 1, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 11, and 12 hours (total of 13 time points) post-dose on Days -1, 1, and 12.
• Baseline-adjusted, placebo-corrected effect on QTc interval (time interval from beginning of the Q wave until end of the T wave (ΔΔQTc interval)) on Day 23 (after 5 days of 100 mg ponesimod)
  Time frame: 23 Days
  Replicate electrocardiograms (ECGs) (at least 3 and up to 10) for the determination of ΔΔQTc interval will be extracted from the continuous digital 12-lead ECG recording within 20 minutes prior to dosing and then at 1, 2, 2.5, 3, 4, 5, 6, 8, 9, 10, 11, and 12 hours (total of 13 time points) post-dose on Days -1, 1, and 23.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The S1P-S1PR Axis in Neurological Disorders-Insights into Current and Future Therapeutic Perspectives.
   Lucaciu A, Brunkhorst R, Pfeilschifter JM, Pfeilschifter W, et al · · 2020 · cited 53× · PMID 32580348 · DOI 10.3390/cells9061515