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NCT04019574 · ClinicalTrials.gov registry record · Phase 1
Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects
A Phase 1 study, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT04019574 is a Phase 1 study that has completed, run by Cara Therapeutics. The registered enrollment target is 57 participants.
The verdict
NCT04019574, a Phase 1 study, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized, double-blind (except for moxifloxacin), placebo- and positive-controlled, single-site, 4-way crossover study to investigate the effects of single therapeutic and supratherapeutic IV doses of difelikefalin (CR845) on the QTc interval in healthy adult subjects. Subjects will be randomized to a treatment sequence consisting of 4 treatment periods with a minimum 5-day washout between treatments. Subjects will receive each of the study treatments over the course of the study. Randomized subjects will receive the assigned study treatment as a single dose in the fasted state in the morning on Day 1 of each treatment period.
Interventions
- OTHER Placebo
- DRUG CR845 0.5 mcg/kg IV
- DRUG CR845 3 mcg/kg IV
- DRUG Moxifloxacin 400 mg Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2019-10-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04019574
The ClinicalTrials.gov registry entry for NCT04019574 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cara Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04019574 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04019574 about?
NCT04019574 is a clinical study titled "Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects". This is a Phase 1, randomized, double-blind (except for moxifloxacin), placebo- and positive-controlled, single-site, 4-way crossover study to investigate the effects of single therapeutic and supratherapeutic IV doses of difelikefalin (CR845) on the QTc interval in healthy adult subjects. Subjects ...
What is the current status of trial NCT04019574?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2019-06-20. Estimated completion is 2019-10-29.
What interventions are being tested in trial NCT04019574?
The interventions under investigation include: Placebo (OTHER), CR845 0.5 mcg/kg IV (DRUG), CR845 3 mcg/kg IV (DRUG), Moxifloxacin 400 mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04019574?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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