Opioid OverdosePhase 1NCT06719986

Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg

A Phase 1 study testing Nalmefene HCl injection and Naloxone HCl intranasal in people with Opioid Overdose, run by Purdue Pharma LP at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Opioid Overdose
What is being tested?: Nalmefene HCl injection and Naloxone HCl intranasal
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 3 Oct 2022to 23 Dec 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.
Body weight ranging from 50 to 100 kg (110-220 lbs) and body mass index (BMI) within the range [18-30] kg/m2 (inclusive).
Willing to be compliant with the protocol, capable of subjective evaluation, if applicable, able to read and understand questionnaires, if applicable.

Who cannot join

Females who are pregnant or lactating.
Any significant illness during the 30 days preceding the initial dose in this study.
History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
Refusal to abstain from caffeine or xanthine containing beverages entirely during confinement.
Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration and through the end-of-study visit.
Difficulty with venous access or unsuitable for or unwilling to undergo catheter insertion.
Other inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio Clinical Trials
Columbus, Ohio, 43212

Other trials in United States

About this study

Official title: A Study to Characterize the Time Course of Reversal of Opioid (Fentanyl)-Induced Respiratory Depression Following Administration of Nalmefene Autoinjector 1.5 mg (0.94% MgCl2) Intramuscular and Narcan® 4 mg Intranasal in Healthy Subjects

Conditions: Opioid Overdose
Being tested: Nalmefene HCl injection, Naloxone HCl intranasal
Medical subject headings: Opiate Overdose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nalmefene HCl injectionDrug
Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration
Naloxone HCl intranasalDrug
Also called Narcan
Naloxone 4 mg for intranasal (IN) administration

Study groups in NCT06719986
Study group	Role	What they receive
Nalmefene Hydrochloride (HCl) injection	Experimental	Nalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration Receives: Drug: Nalmefene HCl injection
Narcan intranasal	Active comparator	Naloxone 4 mg for intranasal (IN) administration Receives: Drug: Naloxone HCl intranasal

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir
To assess the change in minute ventilation at 5 minutes of intramuscular nalmefene and intranasal naloxone reversal from the opioid induced nadir.
Measured: 5 minutes after opioid antagonist administration

Secondary outcomes (12)

Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir
To assess the time course of changes in minute ventilation of intramuscular nalmefene and intranasal naloxone reversal from the opioid induced nadir.
Measured: Baseline, 2.5, 5, 10, 15, 20, 30, and 90 minutes after opioid antagonist administration
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration of nalmefene and naloxone.
Measured: up to 24 hours post-dose
Area Under the Curve (AUC0-2.5)
Area under the plasma concentration-time curve from time zero to 2.5 minutes
Measured: 2.5 minutes post-dose
Area Under the Curve (AUC0-5)
Area under the plasma concentration-time curve from time zero to 5 minutes
Measured: 5 minutes post-dose
Area Under the Curve (AUC0-10)
Area under the plasma concentration-time curve from time zero to 10 minutes
Measured: 10 minutes post-dose
Area Under the Curve (AUC0-15)
Area under the plasma concentration-time curve from time zero to 15 minutes
Measured: 15 minutes post-dose
Area Under the Curve (AUC0-20)
Area under the plasma concentration-time curve from time zero to 20 minutes
Measured: 20 minutes post-dose
Area Under the Curve (AUCt)
Area under the plasma concentration-time curve from time zero to the time of last measurable concentration.
Measured: up to 24 hours post-dose
Area Under the Curve (AUCinf)
Area under the plasma concentration-time curve from time zero to infinity.
Measured: up to 24 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Time to maximum plasma concentration of nalmefene and naloxone.
Measured: up to 24 hours post-dose
Time to First Measurable Plasma Concentration (Tlag)
Time to first measurable plasma concentration of nalmefene and naloxone.
Measured: up to 24 hours post-dose
Half-life (T1/2)
Half life of nalmefene and naloxone.
Measured: up to 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 202223 Dec 2022

First posted6 Dec 2024
Study start3 Oct 2022
Primary completion23 Dec 2022
Study completion23 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid OverdoseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06719986
Sponsor's protocol ID: NAL1004
Status last verified: Jun 2025
First submitted: 2 Dec 2024
Last updated: 3 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual

All Opioid Overdose trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Characterize the Time Course of Reversal of Opioid (Fentanyl)-Induced Respiratory Depression Following Administration of Nalmefene Autoinjector 1.5 mg (0.94% MgCl2) Intramuscular and Narcan® 4 mg Intranasal in Healthy Subjects
ClinicalTrials.gov ID: NCT06719986
Acronym / sponsor ID: NAL1004
Conditions: Opioid Overdose
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: 3 Oct 2022 (actual)
Primary completion: 23 Dec 2022 (actual)
Study completion: 23 Dec 2022 (actual)
First posted: 6 Dec 2024 (actual)
Results: Posted 3 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nalmefene Hydrochloride (HCl) injection	Experimental	Drug: Nalmefene HCl injectionNalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration
Narcan intranasal	Active comparator	Drug: Naloxone HCl intranasalNaloxone 4 mg for intranasal (IN) administration

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.
Body weight ranging from 50 to 100 kg (110-220 lbs) and body mass index (BMI) within the range [18-30] kg/m2 (inclusive).
Willing to be compliant with the protocol, capable of subjective evaluation, if applicable, able to read and understand questionnaires, if applicable.

Key exclusion criteria (7 listed)

Females who are pregnant or lactating.
Any significant illness during the 30 days preceding the initial dose in this study.
History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
Refusal to abstain from caffeine or xanthine containing beverages entirely during confinement.
Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration and through the end-of-study visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nalmefene HCl injectionNalmefene Hydrochloride injection 1.5 mg for intramuscular (IM) administration	Drug	Nalmefene Hydrochloride (HCl) injection
Naloxone HCl intranasalAlso: NarcanNaloxone 4 mg for intranasal (IN) administration	Drug	Narcan intranasal

Primary outcome

Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir
Time frame: 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.

12 secondary outcomes

Change in Minute Ventilation at 2.5, 5, 10, 15, 20, 30, and 90 Minutes From Opioid Induced Nadir
Time frame: Baseline, 2.5, 5, 10, 15, 20, 30, and 90 minutes after opioid antagonist administration
Maximum Plasma Concentration (Cmax)
Time frame: up to 24 hours post-dose
Area Under the Curve (AUC0-2.5)
Time frame: 2.5 minutes post-dose
Area Under the Curve (AUC0-5)
Time frame: 5 minutes post-dose
Area Under the Curve (AUC0-10)
Time frame: 10 minutes post-dose
Area Under the Curve (AUC0-15)
Time frame: 15 minutes post-dose
Area Under the Curve (AUC0-20)
Time frame: 20 minutes post-dose
Area Under the Curve (AUCt)
Time frame: up to 24 hours post-dose
Area Under the Curve (AUCinf)
Time frame: up to 24 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Time frame: up to 24 hours post-dose
Time to First Measurable Plasma Concentration (Tlag)
Time frame: up to 24 hours post-dose
Half-life (T1/2)
Time frame: up to 24 hours post-dose

Results and safety

Results posted to the registry on 3 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fentanyl Infusion	13	13
Sequence 1 (Test-Reference-Test-Reference)	0	0
Sequence 2 (Reference-Test-Reference-Test)	0	0

Primary outcome: Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir

Time frame: 5 minutes after opioid antagonist administration. Mean (Standard Deviation). Unit: L/min

Measure	Nalmefene Hydrochloride (HCl) Injection n = 23	Narcan Intranasal n = 24
Value	4.42 (2.033)	2.03 (0.992)

Population analysed: 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.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: All serious adverse events and adverse events were collected from the signing of the informed consent for study participation through 30 days after the subject's last dose of study drug or within 30 days after the last study visit or follow-up phone call (up to approximately 78 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fentanyl Infusion	0 of 13 (0%)	9 of 13 (69.2%)	0 of 13
Nalmefene Hydrochloride (HCl) Injection	0 of 23 (0%)	20 of 23 (87%)	0 of 23
Narcan Intranasal	0 of 24 (0%)	18 of 24 (75%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Opioid Overdose

Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nalmefene HCl injection and Naloxone HCl intranasal in people with Opioid Overdose, run by Purdue Pharma LP at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir (time frame: 5 minutes after opioid antagonist administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06719986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.