Opioid OverdosePhase 1NCT07543276
Pharmacokinetic (PK) Evaluation of Nalmefene Formulations
A Phase 1 study testing Nalmefene + 0.94% MgCl2 and Nalmefene Hydrochloride Injection in people with Opioid Overdose, run by Knoa Pharma LLC at 1 site in United States.
Trial summary
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects. 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 + 0.94% MgCl2 and Nalmefene Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2026to 3 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body weight ranging from 50 to 100 kg (110-220 lbs) inclusive at screening and body mass index (BMI) within the range [18.0-30.0] kg/m2 (inclusive).
- Willing to be compliant with the protocol, are able to read, understand, and answer verbal questions.
Who cannot join
- Females who are pregnant or lactating.
- Current or recent (within 5 years) history of drug or alcohol abuse.
- History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- Known allergy or hypersensitivity to nalmefene hydrochloride or any of the excipients or other drug product components of nalmefene hydrochloride.
- Dosing in a clinical drug study during the 30 days preceding the initial dose in this study.
- Any significant illness during the 30 days preceding the initial dose in this study
- Other inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open Label, Randomized, Single Dose, Three-Period Crossover Study in Healthy Subjects to Compare the Pharmacokinetic Profiles of Nalmefene Following Administration of Intravenous and Intramuscular Nalmefene 0.5 mg (0.94% MgCl2) and Intravenous Nalmefene Hydrochloride Injection 0.5 mg
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
- Conditions
- Opioid Overdose
- Being tested
- Nalmefene + 0.94% MgCl2, Nalmefene Hydrochloride Injection
- 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 + 0.94% MgCl2Drug
Nalmefene 0.5 mg + 0.94% MgCl2 for IV (bolus) administration
Nalmefene + 0.94% MgCl2Drug
Nalmefene 0.5 mg + 0.94% MgCl2 for IM administration
Nalmefene Hydrochloride InjectionDrug
Nalmefene Hydrochloride Injection 0.5 mg for IV (bolus) administration
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Nalmefene + 0.94% MgCl2 (IV) Receives: Drug: Nalmefene + 0.94% MgCl2 |
| Treatment B | Experimental | Nalmefene + 0.94% MgCl2 (IM) Receives: Drug: Nalmefene + 0.94% MgCl2 |
| Treatment C | Active comparator | Nalmefene Hydrochloride injection Receives: Drug: Nalmefene Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC0-2.5)
Partial area under the plasma concentration-time curve from time zero to 2.5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Measured: 2.5 minutes post-dose
Area Under the Curve (AUC0-5)
Partial area under the plasma concentration-time curve from time zero to 5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Measured: 5 minutes post-dose
Area Under the Curve (AUC0-10)
Partial area under the plasma concentration-time curve from time zero to 10 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Measured: 10 minutes post-dose
Area Under the Curve (AUC0-15)
Partial area under the plasma concentration-time curve from time zero to 15 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Measured: 15 minutes post-dose
Area Under the Curve (AUC0-20)
Partial area under the plasma concentration-time curve from time zero to 20 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Measured: 20 minutes post-dose
Area Under the Curve (AUC0-30)
Partial area under the plasma concentration-time curve from time zero to 30 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Measured: 30 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 following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Measured: Up to 48 hours post-dose
Area Under the Curve (AUCinf)
Area under the plasma concentration-time curve from time zero to infinity following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Measured: Up to 48 hours post-dose
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration of nalmefene following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Measured: Up to 48 hours post-dose
Area Under the Curve (AUC0-2.5)
Partial area under the plasma concentration-time curve from time zero to 2.5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Measured: 2.5 minutes post-dose
Area Under the Curve (AUC0-5)
Partial area under the plasma concentration-time curve from time zero to 5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Measured: 5 minutes post-dose
Area Under the Curve (AUC0-10)
Partial area under the plasma concentration-time curve from time zero to 10 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Measured: 10 minutes post-dose
Area Under the Curve (AUC0-15)
Partial area under the plasma concentration-time curve from time zero to 15 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Measured: 15 minutes post-dose
Area Under the Curve (AUC0-20)
Partial area under the plasma concentration-time curve from time zero to 20 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Measured: 20 minutes post-dose
Area Under the Curve (AUC0-30)
Partial area under the plasma concentration-time curve from time zero to 30 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Measured: 30 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 following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Measured: Up to 48 hours post-dose
Area Under the Curve (AUCinf)
Area under the plasma concentration-time curve from time zero to infinity following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Measured: Up to 48 hours post-dose
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration of nalmefene following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Measured: Up to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start6 Feb 2026
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Knoa Pharma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543276
- Sponsor's protocol ID
- NAL1008
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Randomized, Single Dose, Three-Period Crossover Study in Healthy Subjects to Compare the Pharmacokinetic Profiles of Nalmefene Following Administration of Intravenous and Intramuscular Nalmefene 0.5 mg (0.94% MgCl2) and Intravenous Nalmefene Hydrochloride Injection 0.5 mg
- ClinicalTrials.gov ID
- NCT07543276
- Acronym / sponsor ID
- NAL1008
- Conditions
- Opioid Overdose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Knoa Pharma LLCIndustry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma LP
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Nalmefene + 0.94% MgCl2Nalmefene + 0.94% MgCl2 (IV) |
| Treatment B | Experimental | Drug: Nalmefene + 0.94% MgCl2Nalmefene + 0.94% MgCl2 (IM) |
| Treatment C | Active comparator | Drug: Nalmefene Hydrochloride InjectionNalmefene Hydrochloride injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body weight ranging from 50 to 100 kg (110-220 lbs) inclusive at screening and body mass index (BMI) within the range [18.0-30.0] kg/m2 (inclusive).
- Willing to be compliant with the protocol, are able to read, understand, and answer verbal questions.
Key exclusion criteria (7 listed)
- Females who are pregnant or lactating.
- Current or recent (within 5 years) history of drug or alcohol abuse.
- History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- Known allergy or hypersensitivity to nalmefene hydrochloride or any of the excipients or other drug product components of nalmefene hydrochloride.
- Dosing in a clinical drug study during the 30 days preceding the initial dose in this study.
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 + 0.94% MgCl2Nalmefene 0.5 mg + 0.94% MgCl2 for IV (bolus) administration | Drug | Treatment A |
| Nalmefene + 0.94% MgCl2Nalmefene 0.5 mg + 0.94% MgCl2 for IM administration | Drug | Treatment B |
| Nalmefene Hydrochloride InjectionNalmefene Hydrochloride Injection 0.5 mg for IV (bolus) administration | Drug | Treatment C |
Primary outcome
Area Under the Curve (AUC0-2.5)
Time frame: 2.5 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 2.5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-5)
Time frame: 5 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-10)
Time frame: 10 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 10 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-15)
Time frame: 15 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 15 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-20)
Time frame: 20 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 20 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-30)
Time frame: 30 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 30 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUCt)
Time frame: Up to 48 hours post-dose
Area under the plasma concentration-time curve from time zero to the time of last measurable concentration following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUCinf)
Time frame: Up to 48 hours post-dose
Area under the plasma concentration-time curve from time zero to infinity following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Maximum Plasma Concentration (Cmax)
Time frame: Up to 48 hours post-dose
Maximum plasma concentration of nalmefene following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene hydrochloride injection 0.5 mg IV bolus administration
Area Under the Curve (AUC0-2.5)
Time frame: 2.5 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 2.5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Area Under the Curve (AUC0-5)
Time frame: 5 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 5 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Area Under the Curve (AUC0-10)
Time frame: 10 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 10 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Area Under the Curve (AUC0-15)
Time frame: 15 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 15 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Area Under the Curve (AUC0-20)
Time frame: 20 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 20 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Area Under the Curve (AUC0-30)
Time frame: 30 minutes post-dose
Partial area under the plasma concentration-time curve from time zero to 30 minutes following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Area Under the Curve (AUCt)
Time frame: Up to 48 hours post-dose
Area under the plasma concentration-time curve from time zero to the time of last measurable concentration following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Area Under the Curve (AUCinf)
Time frame: Up to 48 hours post-dose
Area under the plasma concentration-time curve from time zero to infinity following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Maximum Plasma Concentration (Cmax)
Time frame: Up to 48 hours post-dose
Maximum plasma concentration of nalmefene following nalmefene 0.5 mg (0.94% MgCl2) IV bolus administration and nalmefene 0.5 mg (0.94% MgCl2) IM administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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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 + 0.94% MgCl2 and Nalmefene Hydrochloride Injection in people with Opioid Overdose, run by Knoa Pharma LLC 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 5 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area Under the Curve (AUC0-2.5) (time frame: 2.5 minutes post-dose). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.