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NCT04764630 · ClinicalTrials.gov registry record · Phase 1
Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT04764630: Completed Phase 1 study, sponsored by Food and Drug Administration (FDA).
NCT04764630 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04764630, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Intranasal (IN) naloxone is available as 2 mg or 4 mg dose with the indication to re-administer additional doses every 2 to 3 minutes (using alternating nostrils) if needed until emergency medical assistance arrives. The 4 mg dose is distributed in packages of two nasal sprays (1 dose per nasal spray), but additional doses can be administered if needed and available. While the pharmacokinetics of IN naloxone have been determined following administration of a 4 mg dose in each nostril concurrently, the pharmacokinetics have not been determined following multiple doses when there is a 2-3 minute delay between doses and when doses are re-administered to the same nostril. Obtaining data with repeat dosing will inform if and how fast naloxone plasma concentrations can be reached to be able to reverse highly-potent opioid overdoses. This study will be a randomized, unblinded, three-way crossover study to determine naloxone plasma concentration after administration of multiple doses: A. Four 4 mg IN naloxone doses (1 dose every 2.5 minutes) B. Four 4 mg IN naloxone doses (2 doses every 2.5 minutes) C. Two 4 mg IN naloxone doses (1 dose every 2.5 minutes)
Primary Outcome
Naloxone plasma concentrations will be determined at specified timepoints. The four naloxone nasal spray dose arm (1 dose every 2.5 min) will be compared separately to the two naloxone nasal spray dose arm (1 dose every 2.5 min).
Interventions
- DRUG Four naloxone nasal spray doses (1 every 2.5 min)
- DRUG Four naloxone nasal spray doses (2 every 2.5 min)
- DRUG Two naloxone nasal spray doses (1 every 2.5 min)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2021-03-20 |
| Phase | Phase 1 |
What the finished NCT04764630 record still lists
NCT04764630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Four naloxone nasal spray doses (1 every 2.5 min) is the first listed.
NCT04764630 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04764630 about?
NCT04764630 is a clinical study titled "Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone". Intranasal (IN) naloxone is available as 2 mg or 4 mg dose with the indication to re-administer additional doses every 2 to 3 minutes (using alternating nostrils) if needed until emergency medical assistance arrives. The 4 mg dose is distributed in packages of two nasal sprays (1 dose per nasal spra...
What is the current status of trial NCT04764630?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2021-03-01. Estimated completion is 2021-03-20.
What interventions are being tested in trial NCT04764630?
The interventions under investigation include: Four naloxone nasal spray doses (1 every 2.5 min) (DRUG), Four naloxone nasal spray doses (2 every 2.5 min) (DRUG), Two naloxone nasal spray doses (1 every 2.5 min) (DRUG).
Who is sponsoring clinical trial NCT04764630?
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 NCT04764630's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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