Pharmacokinetic Evaluation of Intranasal Nalmefene

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Nalmefene Hydrochloride; Drug: Nalmefene

• Registration Number: NCT04759768
• Lead Sponsor: Opiant Pharmaceuticals Inc

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.

Detailed Description

Open-label, randomized, 2-period, 2-treatment, 2-sequence, crossover study in 68 healthy volunteers. Subjects will be assigned to each of the 2 possible sequences. Each subject will receive 2 treatments during the 2 dosing periods: Intranasal (IN) dose of 3 mg nalmefene hydrochloride and intramuscular (IM) dose of 1.0 mg nalmefene, with a 4 day washout period between doses. Screening can occur up to 28 days before baseline admission, subjects will then stay in the inpatient facility for 7 days to complete the treatment phase of the study and will be discharged following completion of the discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning Adverse Events (AEs) and concomitant medications since discharge.

Study Timeline

• Study Start: 2021-02-08
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-18
• Primary Completion: 2021-05-17
• Study Completion: 2021-05-24
• Results First Submitted: 2023-05-19
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Results First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intranasal Nalmefene	Nalmefene Hydrochloride	Nalmefene hydrochloride nasal spray, 3mg, 1 spray
Intramuscular Nalmefene	Nalmefene	Nalmefene injection, 1mg, 1 injection

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax)	48 hours	Maximum concentration of plasma nalmefene comparing IN to IM
Area Under the Curve (AUC-inf)	48 hours	Area under the curve of plasma nalmefene comparing IN to IM
Time to Maximum Plasma Concentration (Tmax)	48 hours	Time to maximum concentration of plasma nalmefene comparing IN to IM
Half-life (t1/2)	48 hours	Half life of plasma nalmefene comparing IN to IM

Trial Locations

Locations (1)

Worldwide Clinical Trials; 🇺🇸 San Antonio, Texas, United States