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Pharmacokinetic Evaluation of Intranasal Nalmefene

NCT04759768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-08-13

Study results available
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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.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Nalmefene Hydrochloride

3mg nasal spray

DRUG

Nalmefene

1mg intramuscular injection

Sponsors & Collaborators

  • Opiant Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Robert Bass, MD · Worldwide Clinical Trials

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
2021-02-08
Primary Completion
2021-05-17
Completion
2021-05-24
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 NCT04759768 on ClinicalTrials.gov