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NCT01874561 · ClinicalTrials.gov registry record · Phase 1
Thorough QT/QTc (Corrected QT Interval) Study to Evaluate the Effect of Custirsen on Cardiac Repolarization
A Phase 1 study, sponsored by Achieve Life Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 155
- Enrollment target
NCT01874561 is a Phase 1 study that has completed, run by Achieve Life Sciences. The registered enrollment target is 155 participants.
The verdict
NCT01874561, a Phase 1 study, has completed, sponsored by Achieve Life Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 155 participants
- Enrollment target
Study Summary
This is a 3-arm, parallel-group, active- and placebo-controlled, double-blind, randomized study, to compare treatment with intravenous custirsen at 640 mg (highest intended therapeutic dose) with placebo. The purpose of this study is to assess the effect of custirsen treatment on cardiac conduction and repolarization (electrical activity of the heart) in healthy subjects. The positive control employed to demonstrate assay sensitivity consists of a group receiving a single oral dose of 400 mg moxifloxacin on day 7. The moxifloxacin arm is un-blinded but the ECG readings are blinded.
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG Custirsen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01874561
The ClinicalTrials.gov registry entry for NCT01874561 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Achieve Life Sciences, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01874561 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01874561 about?
NCT01874561 is a clinical study titled "Thorough QT/QTc (Corrected QT Interval) Study to Evaluate the Effect of Custirsen on Cardiac Repolarization". This is a 3-arm, parallel-group, active- and placebo-controlled, double-blind, randomized study, to compare treatment with intravenous custirsen at 640 mg (highest intended therapeutic dose) with placebo. The purpose of this study is to assess the effect of custirsen treatment on cardiac conduction ...
What is the current status of trial NCT01874561?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 155 participants. The study started on 2013-05. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01874561?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), Custirsen (DRUG).
Who is sponsoring clinical trial NCT01874561?
This trial is sponsored by Achieve Life Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.
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