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Pharmacodynamic Evaluation of Intranasal Nalmefene

NCT04828005 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-07-14

Study results available
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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

Interventions

DRUG

Nalmefene hydrochloride

3mg Nasal spray

DRUG

Naloxone hydrochloride

4mg Nasal Spray

Sponsors & Collaborators

  • Opiant Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Shawn Searle, MD · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2022-03-14
Completion
2022-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04828005 on ClinicalTrials.gov