Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03070470 · ClinicalTrials.gov registry record · Phase 1
CiPA Phase 1 ECG Biomarker Validation Study
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03070470 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 60 participants.
The verdict
NCT03070470, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study will assess whether exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs that predominantly block the potassium channel encoded by the human ether-à-go-go-related gene (hERG) with approximately equipotent late sodium and/or calcium block ("balanced ion channel" drugs) do not cause J-Tpeakc prolongation and that drugs that predominantly block hERG without late sodium or L-type calcium current block ("predominant hERG" drugs) cause QTc prolongation.
Interventions
- DRUG Placebo
- DRUG Lopinavir / Ritonavir
- DRUG Ranolazine
- DRUG Verapamil
- DRUG Chloroquine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-03-14 |
| Est. Completion | 2017-06-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03070470
The ClinicalTrials.gov registry entry for NCT03070470 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 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 Placebo is the first listed.
NCT03070470 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03070470 about?
NCT03070470 is a clinical study titled "CiPA Phase 1 ECG Biomarker Validation Study". This study will assess whether exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs that predominantly block the potassium channel encoded by the human ether-à-go-go-related gene (hERG) with appro...
What is the current status of trial NCT03070470?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2017-03-14. Estimated completion is 2017-06-26.
What interventions are being tested in trial NCT03070470?
The interventions under investigation include: Placebo (DRUG), Lopinavir / Ritonavir (DRUG), Ranolazine (DRUG), Verapamil (DRUG), Chloroquine (DRUG).
Who is sponsoring clinical trial NCT03070470?
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.