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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 is a Phase 1 study that has completed, run by Actelion. The registered enrollment target is 116 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02136888
The ClinicalTrials.gov registry entry for NCT02136888 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Moxifloxacin Placebo is the first listed.
NCT02136888 reports 0 study locations.
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.
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