Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens

Opioid Overdose Clinical Trial

Official title:

An Open-Label, Three-Period, Three-Treatment, Six-Sequence, Randomized Crossover Study of the Pharmacokinetics of Intranasal Nalmefene in Healthy Volunteers Using Three Dosing Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05219669
• Other study ID #: OPNT003-PK-002
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2021
• Est. completion date: November 22, 2021

Study information

• Verified date: December 2022
• Source: Opiant Pharmaceuticals Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a single dose in each nostril and as two doses in one nostrils; and to evaluate the safety and tolerability of nalmefene IN.

Description:

Open-label, randomized, 3-period, 3-treatment, 6-sequence, ranodmised crossover study in 24 healthy volunteers. Subjects will be assigned to each of the 6 possible sequences. Each subject will receive 3 intranasal (IN) nalmefene doses:

• 3mg IN dose (one 0.1mL spray of a 30mg/mL solution in one nostril)

• 6mg IN dose (one 0.1mL spray of a 30mg/mL solution in each nostril)

• 6mg IN dose (two 0.1mL sprays of a 30mg/mL solution in one nostril) There will be a 6 day washout period between doses. Screening can occur up to 28 days before admission, subjects will then stay in the inpatient facility for 16 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: 24
• Est. completion date: November 22, 2021
• Est. primary completion date: November 19, 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

• Male subjects of childbearing potential that do not agree to use effective contraception

• Male subjects who plan to donate sperm or have female partner(s) who are pregnant, lactating or planning to attempt to become pregnant

• Current or recent upper respiratory tract infection

• Allergic to nalmefene

Related Conditions & MeSH terms

• Opiate Overdose
• Opioid Overdose

Intervention

Drug:
• Nalmefene Hydrochloride
3mg nasal spray

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 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril	48 hours
Primary	Time to maximum plasma concentration (Tmax)	Time to maximum concentration of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril	48 hours
Primary	Area under the curve (AUC)	Area under the curve of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril	48 hours
Primary	Half-life (t1/2)	Half life of plasma nalmefene comparing 1 dose of IN in one nostril to 2 doses of IN in 1 nostril to 1 dose of IN in each nostril	48 hours