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NCT02206204 · ClinicalTrials.gov registry record · Phase 1
Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects
A Phase 1 study of Pharmacokinetics and Safety, sponsored by Actelion.
- Completed
- Registry status
- Phase 1
- Development phase
- 159
- Enrollment target
- 1
- Study location
NCT02206204: Completed Phase 1 study of Pharmacokinetics and Safety, sponsored by Actelion.
NCT02206204 is a Phase 1 study of Pharmacokinetics and Safety that has completed, run by Actelion. The registered enrollment target is 159 participants, above the 58-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (174% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02206204, a Phase 1 study of Pharmacokinetics and Safety, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 159 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxifloxacin and placebo in healthy male and female subjects. The primary objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects. Moxifloxacin is included as a positive control.
Primary Outcome
Electrocardiograms (ECGs) will be extracted in replicate at predefined timepoints from replicated 12-lead Holter ECGs. Cardiodynamic endpoints will be assessed at steady-state for 800 μg selexipag on Day 11 and at steady-state for 1600 μg selexipag on Day 23. Based on prospective criteria, QTcI will be the primary method for heart rate (HR) correction.
Conditions Studied
Interventions
- DRUG moxifloxacin
- DRUG selexipag
- DRUG placebo for selexipag
- DRUG moxifloxacin-matching placebo
Study Locations (1)
Indiana
- Covance Clinical Research Unit - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT02206204 record still lists
NCT02206204 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, above the 58-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (174% higher).
The record links to 4 conditions, with Pharmacokinetics appearing as the primary indexed condition, and to 4 interventions - of which moxifloxacin is the first listed.
NCT02206204 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT02206204 about?
NCT02206204 is a clinical study titled "Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects". This is a single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxifloxacin and placebo in healthy male and female subjects. The primary objective is to demonstrate that ...
What is the current status of trial NCT02206204?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 159 participants. The study started on 2012-06. Estimated completion is 2012-11.
What conditions does trial NCT02206204 study?
This clinical trial studies the following conditions: Pharmacokinetics, Safety, Tolerability, Cardiodynamics.
What interventions are being tested in trial NCT02206204?
The interventions under investigation include: moxifloxacin (DRUG), selexipag (DRUG), placebo for selexipag (DRUG), moxifloxacin-matching placebo (DRUG).
Who is sponsoring clinical trial NCT02206204?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02206204 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02206204's enrollment target sits among peer trials
159 4th of 37 higher than 34 of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
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