Clinical trial NCT04759768: Pharmacokinetic Evaluation of Intranasal Nalmefene
Official title: Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Opiant Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2021-02-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 48 hours
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: 48 hours
measure: Area Under the Curve (AUC-inf)
timeFrame: 48 hours
measure: Half-life (t1/2)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials
state: Texas
Study officials:
affiliation: Worldwide Clinical Trials
name: Robert Bass, MD
role: PRINCIPAL_INVESTIGATOR
References: