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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
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

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

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
~14 spots leftby Dec 2025
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