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NCT02136888 · ClinicalTrials.gov registry record · Phase 1
Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects
A Phase 1 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT02136888: Completed Phase 1 study, sponsored by Actelion.
NCT02136888 is a Phase 1 study that has completed, run by Actelion. The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02136888, a Phase 1 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DRUG Moxifloxacin Placebo
- DRUG Ponesimod Placebo
- DRUG Ponesimod 10 mg
- DRUG Ponesimod 20 mg
- DRUG Ponesimod 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT02136888 record still lists
NCT02136888 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher).
The record links to 0 conditions, and to 5 interventions - of which Moxifloxacin Placebo is the first listed.
NCT02136888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02136888 about?
NCT02136888 is a clinical study titled "Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects". 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 fo...
What is the current status of trial NCT02136888?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2011-08. Estimated completion is 2012-02.
What interventions are being tested in trial NCT02136888?
The interventions under investigation include: Moxifloxacin Placebo (DRUG), Ponesimod Placebo (DRUG), Ponesimod 10 mg (DRUG), Ponesimod 20 mg (DRUG), Ponesimod 40 mg (DRUG).
Who is sponsoring clinical trial NCT02136888?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02136888's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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