Pharmacokinetic Evaluation of Intranasal Nalmefene

NCT04759768 | Completed Phase 1 Results FDA Drug

• 1 other identifier: OPNT003-PK-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Concentration (Cmax)

  Maximum concentration of plasma nalmefene comparing IN to IM

  48 hours

• Time to Maximum Plasma Concentration (Tmax)

  Time to maximum concentration of plasma nalmefene comparing IN to IM

  48 hours

• Area Under the Curve (AUC-inf)

  Area under the curve of plasma nalmefene comparing IN to IM

  48 hours

• Half-life (t1/2)

  Half life of plasma nalmefene comparing IN to IM

  48 hours

Study Arms (2)

Intranasal Nalmefene

EXPERIMENTAL

Nalmefene hydrochloride nasal spray, 3mg, 1 spray

Drug: Nalmefene Hydrochloride

Intramuscular Nalmefene

ACTIVE COMPARATOR

Nalmefene injection, 1mg, 1 injection

Drug: Nalmefene

Interventions

Nalmefene Hydrochloride DRUG

3mg nasal spray

Intranasal Nalmefene

Nalmefene DRUG

1mg intramuscular injection

Intramuscular Nalmefene

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 30 kg/m2, inclusive
• Adequate venous access
• Subjects must be non-smokers

You may not qualify if:

• History of clinically significant disease
• Significant trauma injury, major surgery, open biopsy within 30 days prior to screening
• 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

Sponsors & Collaborators

• Opiant Pharmaceuticals Inc: lead

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Related Publications (1)

• Crystal R, Ellison M, Purdon C, Skolnick P. Pharmacokinetic Properties of an FDA-approved Intranasal Nalmefene Formulation for the Treatment of Opioid Overdose. Clin Pharmacol Drug Dev. 2024 Jan;13(1):58-69. doi: 10.1002/cpdd.1312. Epub 2023 Jul 27.

  PMID: 37496452 DERIVED

MeSH Terms

Interventions

nalmefene

Results Point of Contact

• Title: Clinical Director
• Organization: Opiant Pharmaceuticals

PatientSafetyNA@Indivior.com

18043791090

Study Officials

• Robert Bass, MD

  Worldwide Clinical Trials

  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: February 15, 2021
• First Posted: February 18, 2021
• Study Start: February 8, 2021
• Primary Completion: May 17, 2021
• Study Completion: May 24, 2021
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)