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NCT05716854 · ClinicalTrials.gov registry record · Phase 1
Electrophysiological Effects of Potential QT Prolonging Drugs
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT05716854: Completed Phase 1 study, sponsored by Food and Drug Administration (FDA).
NCT05716854 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05716854, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Since 2005, FDA has required almost all new drugs be tested for their ability to prolong the QT interval through clinical studies. This requirement stems from the increased TdP risk QT interval prolongation can cause. However, the QT interval is an imperfect biomarker, as there are multiple drugs that can prolong the QT interval, without causing increased TdP occurrence. As such, numerous drugs labeled as causing QT prolongation, may in fact have no impact on TdP occurrence. To address this problem, FDA, in collaboration with multiple external partners, has led an initiative to combine novel preclinical in vitro experiments within silico modeling and simulation followed by pharmacodynamic electrocardiographic (ECG) biomarkers. The goal is to use these novel computational and analytical tools to better predict TdP risk (beyond just the QT interval) by focusing on understanding the underlying mechanisms and applying an integrated biological systems approach. This clinical study consists of 2 parts: a 3-arm, 22-subject crossover study (Part 1) and a 4-arm, 22-subject crossover study (Part 2). These parts are included in the same protocol and study due to the similarity of the inclusion and exclusion criteria, similar procedures, and similar primary goals.
Interventions
- DRUG Moxifloxacin
- DRUG Clarithromycin
- DRUG Cobicistat
- DRUG Pimozide
- DRUG Placebo (Part 1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2023-03-21 |
| Est. Completion | 2023-06-13 |
| Phase | Phase 1 |
What the finished NCT05716854 record still lists
NCT05716854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 5 interventions - of which Moxifloxacin is the first listed.
NCT05716854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05716854 about?
NCT05716854 is a clinical study titled "Electrophysiological Effects of Potential QT Prolonging Drugs". Since 2005, FDA has required almost all new drugs be tested for their ability to prolong the QT interval through clinical studies. This requirement stems from the increased TdP risk QT interval prolongation can cause. However, the QT interval is an imperfect biomarker, as there are multiple drugs th...
What is the current status of trial NCT05716854?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2023-03-21. Estimated completion is 2023-06-13.
What interventions are being tested in trial NCT05716854?
The interventions under investigation include: Moxifloxacin (DRUG), Clarithromycin (DRUG), Cobicistat (DRUG), Pimozide (DRUG), Placebo (Part 1) (DRUG).
Who is sponsoring clinical trial NCT05716854?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05716854's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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
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