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Opioid Antagonist

Intranasal Nalmefene for Pharmacokinetics

Phase 1
Waitlist Available
Led By Robert Bass, MD
Research Sponsored by Opiant Pharmaceuticals Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

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 nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Curve (AUC-inf)
Half-life (t1/2)
Maximum Plasma Concentration (Cmax)
+1 more

Side effects data

From 2021 Phase 1 trial • 68 Patients • NCT04759768
56%
nasal discomfort
6%
dizziness
5%
headache
3%
nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intranasal Nalmefene
Intramuscular Nalmefene

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intranasal NalmefeneExperimental Treatment1 Intervention
Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Group II: Intramuscular NalmefeneActive Control1 Intervention
Nalmefene injection, 1mg, 1 injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nalmefene
FDA approved

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Opiant Pharmaceuticals IncLead Sponsor
2 Previous Clinical Trials
108 Total Patients Enrolled
Robert Bass, MDPrincipal InvestigatorWorldwide Clinical Trials
2 Previous Clinical Trials
84 Total Patients Enrolled
~15 spots leftby Oct 2025
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