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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 is a Phase 1 study that has completed, run by Purdue Pharma. The registered enrollment target is 24 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06719986
The ClinicalTrials.gov registry entry for NCT06719986 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nalmefene HCl injection is the first listed.
NCT06719986 reports 0 study locations.
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.
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