Pharmacodynamic Evaluation of Intranasal Nalmefene

NCT04828005 | Completed Phase 1 Results FDA Drug

• 1 other identifier: OPNT003-PD-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacodynamic

Outcome Measures

Primary Outcomes (1)

• Change in Minute Ventilation

  Change in minute ventilation from opioid induced nadir

  5 minutes

Secondary Outcomes (7)

• Maximum Change in Minute Ventilation

  Up to 2 hours

• Time to Maximum Change in Minute Ventilation

  Up to 2 hours

• Change in Minute Ventilation

  90 minutes

• Change in Minute Ventilation

  20 minutes

• Change in Minute Ventilation

  15 minutes

Study Arms (2)

Intranasal Nalmefene

EXPERIMENTAL

Nalmefene hydrochloride nasal spray, 3mg, 1 spray

Drug: Nalmefene hydrochloride

Intranasal Naloxone

ACTIVE COMPARATOR

Naloxone hydrochloride nasal spray, 4mg, 1 spray

Drug: Naloxone hydrochloride

Interventions

Nalmefene hydrochloride DRUG

3mg Nasal spray

Intranasal Nalmefene

Naloxone hydrochloride DRUG

4mg Nasal Spray

Intranasal Naloxone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Opiant Pharmaceuticals Inc: lead

Study Sites (1)

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

nalmefene; Naloxone

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Director
• Organization: Opiant Pharmaceuticals

PatientSafetyNA@Indivior.com

+1 804 379 1090

Study Officials

• Shawn Searle, MD

  PRA Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: March 30, 2021
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)