Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00839891 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers
A Phase 1 study of Torsades de Pointes, sponsored by VIVUS.
- Completed
- Registry status
- Phase 1
- Development phase
- 112
- Enrollment target
- 1
- Study location
NCT00839891: Completed Phase 1 study of Torsades de Pointes, sponsored by VIVUS.
NCT00839891 is a Phase 1 study of Torsades de Pointes that has completed, run by VIVUS. The registered enrollment target is 112 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00839891, a Phase 1 study of Torsades de Pointes, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 112 participants
- Enrollment target
- 1
- Study location
Study Summary
* Determine whether VI-0521 has an effect on the electrical activity of the heart in healthy subjects. * Find out how much VI-0521 is in the blood and any potential side effects on ECG's of healthy subjects after taking the study drugs.
Conditions Studied
Interventions
- DRUG VI-0521
Study Locations (1)
Arizona
- MDS Pharma Services - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-04 |
| Phase | Phase 1 |
What the finished NCT00839891 record still lists
NCT00839891 is an interventional study that assigns participants to a tested intervention. The registered 112 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 (87% higher).
The record links to 1 condition, with Torsades de Pointes appearing as the primary indexed condition, and to 1 intervention - of which VI-0521 is the first listed.
NCT00839891 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT00839891 about?
NCT00839891 is a clinical study titled "A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers". * Determine whether VI-0521 has an effect on the electrical activity of the heart in healthy subjects. * Find out how much VI-0521 is in the blood and any potential side effects on ECG's of healthy subjects after taking the study drugs.
What is the current status of trial NCT00839891?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2009-02. Estimated completion is 2009-04.
What conditions does trial NCT00839891 study?
This clinical trial studies the following conditions: Torsades de Pointes.
What interventions are being tested in trial NCT00839891?
The interventions under investigation include: VI-0521 (DRUG).
Who is sponsoring clinical trial NCT00839891?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00839891 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00839891's enrollment target sits among peer trials
112 508th of 2000 higher than 1,489 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
- NCT04511013 · 112 participants · Phase 2
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
- NCT04551560 · 112 participants · NA
Stress and Congestive Heart Failure
- NCT04872166 · 112 participants · Phase 1
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
- NCT05024773 · 112 participants · Phase 3
Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID)
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