Trial · NCT06719986
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
NCT06719986, Phase 1, Completed, Purdue Pharma LP; results first posted 2025-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg. Trials, record NCT06719986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06719986
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
- NCT number
- NCT06719986
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Purdue Pharma LP
- Conditions
- Opioid Overdose
- Interventions
- Nalmefene HCl injection, Naloxone HCl intranasal
- First posted
- 2024-12-06
- Last updated
- 2025-07-03
- Results first posted
- 2025-07-03
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir | 5 minutes after opioid antagonist administration | To assess the change in minute ventilation at 5 minutes of intramuscular nalmefene and intranasal naloxone reversal from the opioid induced nadir. |
| Secondary | Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir | Baseline, 2.5, 5, 10, 15, 20, 30, and 90 minutes after opioid antagonist administration | To assess the time course of changes in minute ventilation of intramuscular nalmefene and intranasal naloxone reversal from the opioid induced nadir. |
| Secondary | Maximum Plasma Concentration (Cmax) | up to 24 hours post-dose | Maximum plasma concentration of nalmefene and naloxone. |
| Secondary | Area Under the Curve (AUC0-2.5) | 2.5 minutes post-dose | Area under the plasma concentration-time curve from time zero to 2.5 minutes |
| Secondary | Area Under the Curve (AUC0-5) | 5 minutes post-dose | Area under the plasma concentration-time curve from time zero to 5 minutes |
| Secondary | Area Under the Curve (AUC0-10) | 10 minutes post-dose | Area under the plasma concentration-time curve from time zero to 10 minutes |
| Secondary | Area Under the Curve (AUC0-15) | 15 minutes post-dose | Area under the plasma concentration-time curve from time zero to 15 minutes |
| Secondary | Area Under the Curve (AUC0-20) | 20 minutes post-dose | Area under the plasma concentration-time curve from time zero to 20 minutes |
| Secondary | Area Under the Curve (AUCt) | up to 24 hours post-dose | Area under the plasma concentration-time curve from time zero to the time of last measurable concentration. |
| Secondary | Area Under the Curve (AUCinf) | up to 24 hours post-dose | Area under the plasma concentration-time curve from time zero to infinity. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir | 5 minutes after opioid antagonist administration | Eligible analysis set was defined as subjects/periods who were randomized, received study drug, had at least 1 valid pharmacodynamic (PD) measurement, and their opioid-induced respiratory depressions (OIRDs) were worse than baseline for minute ventilation (MV) and transcutaneous CO2 (TCO2). The data for the overall treatment period was calculated as the average of available data from individual periods. | L/min | MEAN |
| SECONDARY | Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir | Baseline, 2.5, 5, 10, 15, 20, 30, and 90 minutes after opioid antagonist administration | Eligible analysis set was defined as subjects/periods who were randomized, received study drug, had at least 1 valid pharmacodynamic (PD) measurement, and their opioid-induced respiratory depressions (OIRDs) were worse than baseline for minute ventilation (MV) and transcutaneous CO2 (TCO2). The data for overall treatment period was calculated as the average of available data from individual periods. | L/min | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) | up to 24 hours post-dose | Full analysis population was defined as all subjects who were randomized, received study drug and had at least 1 valid pharmacodynamics (PD) measurement. Pharmacokinetic analyses and summaries were based on the full analysis population. For the overall analysis, the values were averaged within each subject first, then the descriptive statistics were calculated. | ng/mL | MEAN |
| SECONDARY | Area Under the Curve (AUC0-2.5) | 2.5 minutes post-dose | Full analysis population was defined as all subjects who were randomized, received study drug and had at least 1 valid pharmacodynamics (PD) measurement. Pharmacokinetic analyses and summaries were based on the full analysis population. For the overall analysis, the values were averaged within each subject first, then the descriptive statistics were calculated. | ng*hr/mL | MEAN |
| SECONDARY | Area Under the Curve (AUC0-5) | 5 minutes post-dose | Full analysis population was defined as all subjects who were randomized, received study drug and had at least 1 valid pharmacodynamics (PD) measurement. Pharmacokinetic analyses and summaries were based on the full analysis population. For the overall analysis, the values were averaged within each subject first, then the descriptive statistics were calculated. | ng*hr/mL | MEAN |
| SECONDARY | Area Under the Curve (AUC0-10) | 10 minutes post-dose | Full analysis population was defined as all subjects who were randomized, received study drug and had at least 1 valid pharmacodynamics (PD) measurement. Pharmacokinetic analyses and summaries were based on the full analysis population. For the overall analysis, the values were averaged within each subject first, then the descriptive statistics were calculated. | ng*hr/mL | MEAN |
| SECONDARY | Area Under the Curve (AUC0-15) | 15 minutes post-dose | Full analysis population was defined as all subjects who were randomized, received study drug and had at least 1 valid pharmacodynamics (PD) measurement. Pharmacokinetic analyses and summaries were based on the full analysis population. For the overall analysis, the values were averaged within each subject first, then the descriptive statistics were calculated. | ng*hr/mL | MEAN |
| SECONDARY | Area Under the Curve (AUC0-20) | 20 minutes post-dose | Full analysis population was defined as all subjects who were randomized, received study drug and had at least 1 valid pharmacodynamics (PD) measurement. Pharmacokinetic analyses and summaries were based on the full analysis population. For the overall analysis, the values were averaged within each subject first, then the descriptive statistics were calculated. | ng*hr/mL | MEAN |
| SECONDARY | Area Under the Curve (AUCt) | up to 24 hours post-dose | Full analysis population was defined as all subjects who were randomized, received study drug and had at least 1 valid pharmacodynamics (PD) measurement. Pharmacokinetic analyses and summaries were based on the full analysis population. For the overall analysis, the values were averaged within each subject first, then the descriptive statistics were calculated. | ng*hr/mL | MEAN |
| SECONDARY | Area Under the Curve (AUCinf) | up to 24 hours post-dose | Full analysis population was defined as all subjects who were randomized, received study drug and had at least 1 valid pharmacodynamics (PD) measurement. Pharmacokinetic analyses and summaries were based on the full analysis population. For the overall analysis, the values were averaged within each subject first, then the descriptive statistics were calculated. | ng*hr/mL | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir | Nalmefene Hydrochloride (HCl) Injection | 4.42 | Standard Deviation 2.033 | L/min | |
| Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir | Narcan Intranasal | 2.03 | Standard Deviation 0.992 | L/min | |
| Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir | Nalmefene Hydrochloride (HCl) Injection | Baseline | 2.92 | Standard Deviation 1.254 | L/min |
| Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir | Narcan Intranasal | Baseline | 3.02 | Standard Deviation 1.022 | L/min |
| Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir | Nalmefene Hydrochloride (HCl) Injection | 2.5 minutes | 2.00 | Standard Deviation 1.284 | L/min |
| Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir | Narcan Intranasal | 2.5 minutes | 1.67 | Standard Deviation 1.046 | L/min |
| Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir | Nalmefene Hydrochloride (HCl) Injection | 5 minutes | 4.42 | Standard Deviation 2.033 | L/min |
| Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir | Narcan Intranasal | 5 minutes | 2.03 | Standard Deviation 0.992 | L/min |
| Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir | Nalmefene Hydrochloride (HCl) Injection | 10 minutes | 3.97 | Standard Deviation 1.755 | L/min |
| Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir | Narcan Intranasal | 10 minutes | 2.57 | Standard Deviation 1.364 | L/min |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow81
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 Qualification (1 Day) | STARTED | Fentanyl Infusion | 13 | |
| Part 1 Qualification (1 Day) | STARTED | Sequence 1 (Test-Reference-Test-Reference) | 0 | |
| Part 1 Qualification (1 Day) | STARTED | Sequence 2 (Reference-Test-Reference-Test) | 0 | |
| Part 1 Qualification (1 Day) | COMPLETED | Fentanyl Infusion | 13 | |
| Part 1 Qualification (1 Day) | COMPLETED | Sequence 1 (Test-Reference-Test-Reference) | 0 | |
| Part 1 Qualification (1 Day) | COMPLETED | Sequence 2 (Reference-Test-Reference-Test) | 0 | |
| Part 1 Qualification (1 Day) | NOT COMPLETED | Fentanyl Infusion | 0 | |
| Part 1 Qualification (1 Day) | NOT COMPLETED | Sequence 1 (Test-Reference-Test-Reference) | 0 | |
| Part 1 Qualification (1 Day) | NOT COMPLETED | Sequence 2 (Reference-Test-Reference-Test) | 0 | |
| Qualification Washout (12 Hours) | STARTED | Fentanyl Infusion | 13 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 participant flowAdverse events75
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Fentanyl Infusion | 0 | 13 | |
| other | Palpitations | Cardiac disorders | Nalmefene Hydrochloride (HCl) Injection | 4 | 23 | |
| other | Palpitations | Cardiac disorders | Narcan Intranasal | 0 | 24 | |
| other | Tinnitus | Ear and labyrinth disorders | Fentanyl Infusion | 0 | 13 | |
| other | Tinnitus | Ear and labyrinth disorders | Nalmefene Hydrochloride (HCl) Injection | 4 | 23 | |
| other | Tinnitus | Ear and labyrinth disorders | Narcan Intranasal | 0 | 24 | |
| other | Ear discomfort | Ear and labyrinth disorders | Fentanyl Infusion | 0 | 13 | |
| other | Ear discomfort | Ear and labyrinth disorders | Nalmefene Hydrochloride (HCl) Injection | 3 | 23 | |
| other | Ear discomfort | Ear and labyrinth disorders | Narcan Intranasal | 0 | 24 | |
| other | Nausea | Gastrointestinal disorders | Fentanyl Infusion | 1 | 13 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fentanyl Infusion | 0 | 13 |
| Total, all-cause mortality | Nalmefene Hydrochloride (HCl) Injection | 0 | 23 |
| Total, all-cause mortality | Narcan Intranasal | 0 | 24 |
| Total, other adverse events | Fentanyl Infusion | 9 | 13 |
| Total, other adverse events | Nalmefene Hydrochloride (HCl) Injection | 20 | 23 |
| Total, other adverse events | Narcan Intranasal | 18 | 24 |
| Total, serious adverse events | Fentanyl Infusion | 0 | 13 |
| Total, serious adverse events | Nalmefene Hydrochloride (HCl) Injection | 0 | 23 |
| Total, serious adverse events | Narcan Intranasal | 0 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06719986
GET https://conductscience.org/api/trials/v1/NCT06719986/results?page=2