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NCT06719986 · ClinicalTrials.gov registry record · Phase 1
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
A Phase 1 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT06719986: Completed Phase 1 study, sponsored by Purdue Pharma.
NCT06719986 is a Phase 1 study that has completed, run by Purdue Pharma. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06719986, a Phase 1 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into the nose) to healthy subjects with prior opioid exposure under steady state fentanyl concentrations (opioid agonism).
Primary Outcome
To assess the change in minute ventilation at 5 minutes of intramuscular nalmefene and intranasal naloxone reversal from the opioid induced nadir.
Interventions
- DRUG Nalmefene HCl injection
- DRUG Naloxone HCl intranasal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2022-12-23 |
| Phase | Phase 1 |
What the finished NCT06719986 record still lists
NCT06719986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Nalmefene HCl injection is the first listed.
NCT06719986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06719986 about?
NCT06719986 is a clinical study titled "Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg". The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into the nose) to healthy subjects with prior opioid exposure under steady s...
What is the current status of trial NCT06719986?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-10-03. Estimated completion is 2022-12-23.
What interventions are being tested in trial NCT06719986?
The interventions under investigation include: Nalmefene HCl injection (DRUG), Naloxone HCl intranasal (DRUG).
Who is sponsoring clinical trial NCT06719986?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06719986's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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