PharmacokineticsPhase 1NCT04759768
Pharmacokinetic Evaluation of Intranasal Nalmefene
A Phase 1 study testing Nalmefene Hydrochloride and Nalmefene in people with Pharmacokinetics, run by Opiant Pharmaceuticals Inc at 1 site in United States.
Trial summary
This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Nalmefene Hydrochloride and Nalmefene
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 24 May 2021
- 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
- Male or female aged 18 to 55 years inclusive
- BMI ranging from 18 to 30 kg/m2, inclusive
- Adequate venous access
- Subjects must be non-smokers
Who cannot join
- History of clinically significant disease
- Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
- Following an abnormal diet 4 weeks prior to screening
- Use of over the counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention
- Use of enzyme altering drugs 30 days before intervention
- Use of nasal products 28 days before intervention and throughout the study
Show all 12Show fewer
- Previous or current opioid, alcohol, or other drug dependence
- Donated or received blood 30 days before intervention
- Women who are pregnant or breastfeeding at screening
- Women of childbearing potential unless surgically sterile or use effective contraception
- Current or recent upper respiratory tract infection
- Allergic to nalmefene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers
This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.
Read the detailed description
Open-label, randomized, 2-period, 2-treatment, 2-sequence, crossover study in 68 healthy volunteers. Subjects will be assigned to each of the 2 possible sequences. Each subject will receive 2 treatments during the 2 dosing periods: Intranasal (IN) dose of 3 mg nalmefene hydrochloride and intramuscular (IM) dose of 1.0 mg nalmefene, with a 4 day washout period between doses. Screening can occur up to 28 days before baseline admission, subjects will then stay in the inpatient facility for 7 days to complete the treatment phase of the study and will be discharged following completion of the discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning Adverse Events (AEs) and concomitant medications since discharge.
- Conditions
- Pharmacokinetics
- Being tested
- Nalmefene Hydrochloride, Nalmefene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalmefene HydrochlorideDrug
3mg nasal spray
NalmefeneDrug
1mg intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Nalmefene | Experimental | Nalmefene hydrochloride nasal spray, 3mg, 1 spray Receives: Drug: Nalmefene Hydrochloride |
| Intramuscular Nalmefene | Active comparator | Nalmefene injection, 1mg, 1 injection Receives: Drug: Nalmefene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Maximum concentration of plasma nalmefene comparing IN to IM
Measured: 48 hours
Time to Maximum Plasma Concentration (Tmax)
Time to maximum concentration of plasma nalmefene comparing IN to IM
Measured: 48 hours
Area Under the Curve (AUC-inf)
Area under the curve of plasma nalmefene comparing IN to IM
Measured: 48 hours
Half-life (t1/2)
Half life of plasma nalmefene comparing IN to IM
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start8 Feb 2021
- Primary completion17 May 2021
- Study completion24 May 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opiant Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Bass, MD, Principal investigator, Worldwide Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759768
- Sponsor's protocol ID
- OPNT003-PK-001
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2021
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crystal R, Ellison M, Purdon C, Skolnick P. Pharmacokinetic Properties of an FDA-approved Intranasal Nalmefene Formulation for the Treatment of Opioid Overdose. Clin Pharmacol Drug Dev. 2024 Jan;13(1):58-69. doi: 10.1002/cpdd.1312. Epub 2023 Jul 27.
PubMed 37496452
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04759768
- Acronym / sponsor ID
- OPNT003-PK-001
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Opiant Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Posted 13 Aug 2024
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 to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.
Detailed description
Open-label, randomized, 2-period, 2-treatment, 2-sequence, crossover study in 68 healthy volunteers. Subjects will be assigned to each of the 2 possible sequences. Each subject will receive 2 treatments during the 2 dosing periods: Intranasal (IN) dose of 3 mg nalmefene hydrochloride and intramuscular (IM) dose of 1.0 mg nalmefene, with a 4 day washout period between doses. Screening can occur up to 28 days before baseline admission, subjects will then stay in the inpatient facility for 7 days to complete the treatment phase of the study and will be discharged following completion of the discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning Adverse Events (AEs) and concomitant medications since discharge.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Nalmefene | Experimental | Drug: Nalmefene HydrochlorideNalmefene hydrochloride nasal spray, 3mg, 1 spray |
| Intramuscular Nalmefene | Active comparator | Drug: NalmefeneNalmefene injection, 1mg, 1 injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female aged 18 to 55 years inclusive
- BMI ranging from 18 to 30 kg/m2, inclusive
- Adequate venous access
- Subjects must be non-smokers
Key exclusion criteria (12 listed)
- History of clinically significant disease
- Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
- Following an abnormal diet 4 weeks prior to screening
- Use of over the counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention
- Use of enzyme altering drugs 30 days before intervention
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 Hydrochloride3mg nasal spray | Drug | Intranasal Nalmefene |
| Nalmefene1mg intramuscular injection | Drug | Intramuscular Nalmefene |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: 48 hours
Maximum concentration of plasma nalmefene comparing IN to IM
Time to Maximum Plasma Concentration (Tmax)
Time frame: 48 hours
Time to maximum concentration of plasma nalmefene comparing IN to IM
Area Under the Curve (AUC-inf)
Time frame: 48 hours
Area under the curve of plasma nalmefene comparing IN to IM
Half-life (t1/2)
Time frame: 48 hours
Half life of plasma nalmefene comparing IN to IM
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37496452Crystal R, Ellison M, Purdon C, Skolnick P. Pharmacokinetic Properties of an FDA-approved Intranasal Nalmefene Formulation for the Treatment of Opioid Overdose. Clin Pharmacol Drug Dev. 2024 Jan;13(1):58-69. doi: 10.1002/cpdd.1312. Epub 2023 Jul 27.
- Individual participant dataSharing planned: No
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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.
Robert Bass, MD principal investigator
Worldwide Clinical Trials
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 Hydrochloride and Nalmefene in people with Pharmacokinetics, run by Opiant Pharmaceuticals Inc 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 4 inclusion and 12 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 13 Aug 2024. 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 13 Aug 2024). 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?
Maximum Plasma Concentration (Cmax) (time frame: 48 hours). The study lists 4 primary outcomes in all. 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 NCT04759768, which also lists 1 linked publication.
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 13 Aug 2024.