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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: Completed Phase 1 study, sponsored by Food and Drug Administration (FDA).
NCT03070470 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measure for the "balanced ion channel" drugs (ranolazine, verapamil, lopinavir / ritonavir) is for the upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model. Placebo drug concentration was set to 0 (see SAP).
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 |
What the finished NCT03070470 record still lists
NCT03070470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03070470 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03070470's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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