Pharmacokinetic Evaluation of Intranasal Nalmefene

Pharmacokinetics Clinical Trial

Official title:

Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759768
• Other study ID #: OPNT003-PK-001
• Status: Completed
• Phase: Phase 1
• Start date: February 8, 2021
• Est. completion date: May 24, 2021

Study information

• Verified date: October 2021
• Source: Opiant Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 24, 2021
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Nalmefene Hydrochloride
3mg nasal spray
• Nalmefene
1mg intramuscular injection

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Opiant Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)	Maximum concentration of plasma nalmefene comparing IN to IM	48 hours
Primary	Time to maximum plasma concentration (Tmax)	Time to maximum concentration of plasma nalmefene comparing IN to IM	48 hours
Primary	Area under the curve (AUC)	Area under the curve of plasma nalmefene comparing IN to IM	48 hours
Primary	Half-life (t1/2)	Half life of plasma nalmefene comparing IN to IM	48 hours