Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Achieve Life Sciences.
NCT01874561 is a Phase 1 study that has completed, run by Achieve Life Sciences. The registered enrollment target is 155 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (158% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary ECG variable and endpoint for this study is the time-matched change from baseline in QTcI method on day 7 at each time point. Holter ECGs will be performed at baseline (day -1) and prior to the start of infusion on day 7 and 1, 2 (end of infusion), 2.5, 3, 4, 5, 6, 8, 12, 16, 20, and 23.5 hours after the start of infusion.
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 |
What the finished NCT01874561 record still lists
NCT01874561 is an interventional study that assigns participants to a tested intervention. The registered 155 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 (158% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01874561 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01874561's enrollment target sits among peer trials
155 352nd of 2000 higher than 1,645 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03223610 · 155 participants · Phase 1
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
- NCT05072483 · 155 participants
Natural History Study of CADASIL
- NCT05086497 · 155 participants · NA
WBSI Guided Personalized Delivery of TTFields
- NCT05412069 · 155 participants · NA
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia