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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 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 44 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05716854
The ClinicalTrials.gov registry entry for NCT05716854 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Food and Drug Administration (FDA), which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Moxifloxacin is the first listed.
NCT05716854 reports 0 study locations.
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.
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