PharmacodynamicPhase 1NCT04828005
Pharmacodynamic Evaluation of Intranasal Nalmefene
A Phase 1 study testing Nalmefene hydrochloride and Naloxone hydrochloride in people with Pharmacodynamic, run by Opiant Pharmaceuticals Inc at 1 site in United States.
Trial summary
This study is to determine the pharmacodynamics (the effects of the drug and mechanisms of their action within the body) of Nalmefene when given intranasally (IN; into the nose) compared to intranasal naloxone when given to healthy volunteers under steady state opioid agonism. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacodynamic
- What is being tested?
- Nalmefene hydrochloride and Naloxone hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 14 Mar 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
- Male or female aged 18 to 55 years inclusive
- BMI ranging from 18 to 32 kg/m2, inclusive
- Adequate venous access
- Healthy subjects and non-dependent who are non dependent opioid experienced users, opioid experience defined as exposure to an opioid on at least 1 occasion prior to screening
Who cannot join
- History of clinically significant disease
- Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
- Subject who has a difficult airway for intubation.
- 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
Show all 13Show fewer
- Use of nasal products 28 days before intervention and throughout the study
- 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 or naloxone or known hypersensitivity reaction to plastics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part Open Label Study of the Pharmacodynamic Effects of Intranasal Nalmefene Compared to Intranasal Naloxone in Healthy Volunteers Under Steady State Opioid Agonism
This study is to determine the pharmacodynamics (the effects of the drug and mechanisms of their action within the body) of Nalmefene when given intranasally (IN; into the nose) compared to intranasal naloxone when given to healthy volunteers under steady state opioid agonism.
Read the detailed description
Open-label, 2-part study. Part 1 is a pilot study to determine the relationship between opioid agonism and suppression of carbon dioxide induced increases in minute ventilation prior to opioid exposure. Part 2 will be a randomized, 2 period, 2 treatment, crossover study to evaluate the pharmacodynamic effects of intranasal (IN) nalmefene compared to IN naloxone to reverse opioid-induced suppression of carbon dioxide induced increases in minute ventilation, in healthy volunteers with prior opioid exposure.
Both Part 1 and Part 2 of the study will consist of an outpatient Screening Visit taking place 28 days prior to admission, an in-clinic Treatment Phase consisting of a 6 or 7 day inpatient stay, and a Follow-Up Phone Call conducted 3 to 7 days after discharge.
- Conditions
- Pharmacodynamic
- Being tested
- Nalmefene hydrochloride, Naloxone hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalmefene hydrochlorideDrug
3mg Nasal spray
Naloxone hydrochlorideDrug
4mg Nasal Spray
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Nalmefene | Experimental | Nalmefene hydrochloride nasal spray, 3mg, 1 spray Receives: Drug: Nalmefene hydrochloride |
| Intranasal Naloxone | Active comparator | Naloxone hydrochloride nasal spray, 4mg, 1 spray Receives: Drug: Naloxone hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Minute Ventilation
Change in minute ventilation from opioid induced nadir
Measured: 5 minutes
Secondary outcomes (7)
Maximum Change in Minute Ventilation
Maximum change in minute ventilation from opioid induced nadir
Measured: Up to 2 hours
Time to Maximum Change in Minute Ventilation
Time to maximum change in minute ventilation from opioid induced nadir
Measured: Up to 2 hours
Change in Minute Ventilation
Change in minute ventilation from opioid induced nadir
Measured: 90 minutes
Change in Minute Ventilation
Change in minute ventilation from opioid induced nadir
Measured: 20 minutes
Change in Minute Ventilation
Change in minute ventilation from opioid induced nadir
Measured: 15 minutes
Change in Minute Ventilation
Change in minute ventilation from opioid induced nadir
Measured: 10 minutes
Change in Minute Ventilation
Change in minute ventilation from opioid induced nadir
Measured: 2.5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start30 Mar 2021
- Primary completion14 Mar 2022
- Study completion14 Mar 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 PharmacodynamicStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Opiant Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shawn Searle, MD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828005
- Sponsor's protocol ID
- OPNT003-PD-001
- Status last verified
- Jun 2025
- First submitted
- 30 Mar 2021
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Open Label Study of the Pharmacodynamic Effects of Intranasal Nalmefene Compared to Intranasal Naloxone in Healthy Volunteers Under Steady State Opioid Agonism
- ClinicalTrials.gov ID
- NCT04828005
- Acronym / sponsor ID
- OPNT003-PD-001
- Conditions
- Pharmacodynamic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Opiant Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 14 Jul 2025
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 pharmacodynamics (the effects of the drug and mechanisms of their action within the body) of Nalmefene when given intranasally (IN; into the nose) compared to intranasal naloxone when given to healthy volunteers under steady state opioid agonism.
Detailed description
Open-label, 2-part study. Part 1 is a pilot study to determine the relationship between opioid agonism and suppression of carbon dioxide induced increases in minute ventilation prior to opioid exposure. Part 2 will be a randomized, 2 period, 2 treatment, crossover study to evaluate the pharmacodynamic effects of intranasal (IN) nalmefene compared to IN naloxone to reverse opioid-induced suppression of carbon dioxide induced increases in minute ventilation, in healthy volunteers with prior opioid exposure.
Both Part 1 and Part 2 of the study will consist of an outpatient Screening Visit taking place 28 days prior to admission, an in-clinic Treatment Phase consisting of a 6 or 7 day inpatient stay, and a Follow-Up Phone Call conducted 3 to 7 days after 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 |
| Intranasal Naloxone | Active comparator | Drug: Naloxone hydrochlorideNaloxone hydrochloride nasal spray, 4mg, 1 spray |
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 32 kg/m2, inclusive
- Adequate venous access
- Healthy subjects and non-dependent who are non dependent opioid experienced users, opioid experience defined as exposure to an opioid on at least 1 occasion prior to screening
Key exclusion criteria (13 listed)
- History of clinically significant disease
- Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
- Subject who has a difficult airway for intubation.
- 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
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 |
| Naloxone hydrochloride4mg Nasal Spray | Drug | Intranasal Naloxone |
Primary outcome
Change in Minute Ventilation
Time frame: 5 minutes
Change in minute ventilation from opioid induced nadir
7 secondary outcomes
Maximum Change in Minute Ventilation
Time frame: Up to 2 hours
Time to Maximum Change in Minute Ventilation
Time frame: Up to 2 hours
Change in Minute Ventilation
Time frame: 90 minutes
Change in Minute Ventilation
Time frame: 20 minutes
Change in Minute Ventilation
Time frame: 15 minutes
Change in Minute Ventilation
Time frame: 10 minutes
Change in Minute Ventilation
Time frame: 2.5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Shawn Searle, MD principal investigator
PRA Health Sciences
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 Naloxone hydrochloride in people with Pharmacodynamic, 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 13 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 14 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 14 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 (time frame: 5 minutes). 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 14 Jul 2025.