Phase 1
N=7
Pharmacodynamic Evaluation of Intranasal Nalmefene
Pharmacodynamic
Bottom Line
View on ClinicalTrials.gov: NCT04828005 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Minute Ventilation — 3.432; 5.744 L/min — p=<0.0009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Nalmefene hydrochloride (Drug); Naloxone hydrochloride (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Opiant Pharmaceuticals Inc
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Minute Ventilation |
2.55; 1.71 | — |
| SECONDARY Maximum Change in Minute Ventilation |
6.8; 5.8 | — |
| SECONDARY Time to Maximum Change in Minute Ventilation |
0.50; 0.75 | — |
| SECONDARY Change in Minute Ventilation |
2.55; 1.71 | — |
| SECONDARY Change in Minute Ventilation |
2.55; 1.71 | — |
| SECONDARY Change in Minute Ventilation |
2.55; 1.71 | — |
| SECONDARY Change in Minute Ventilation |
2.55; 1.71 | — |
| SECONDARY Change in Minute Ventilation |
2.55; 1.71 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT04828005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.