Pharmacokinetic Evaluation of Intranasal Nalmefene

• ClinicalTrials.gov Identifier: NCT04759768
• Recruitment Status: Completed
• First Posted: February 18, 2021
• Last Update Posted: October 22, 2021
• Sponsor: Opiant Pharmaceuticals Inc
• Information provided by (Responsible Party): Opiant Pharmaceuticals Inc

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pharmacokinetics	Drug: Nalmefene Hydrochloride; Drug: Nalmefene	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers
• Actual Study Start Date: February 8, 2021
• Actual Primary Completion Date: May 17, 2021
• Actual Study Completion Date: May 24, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intranasal Nalmefene; Nalmefene hydrochloride nasal spray, 3mg, 1 spray	Drug: Nalmefene Hydrochloride; 3mg nasal spray
Active Comparator: Intramuscular Nalmefene; Nalmefene injection, 1mg, 1 injection	Drug: Nalmefene; 1mg intramuscular injection

Outcome Measures

Primary Outcome Measures :

1. Maximum plasma concentration (Cmax) [ Time Frame: 48 hours ]
   Maximum concentration of plasma nalmefene comparing IN to IM
2. Time to maximum plasma concentration (Tmax) [ Time Frame: 48 hours ]
   Time to maximum concentration of plasma nalmefene comparing IN to IM
3. Area under the curve (AUC) [ Time Frame: 48 hours ]
   Area under the curve of plasma nalmefene comparing IN to IM
4. Half-life (t1/2) [ Time Frame: 48 hours ]
   Half life of plasma nalmefene comparing IN to IM

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Texas

Worldwide Clinical Trials

San Antonio, Texas, United States, 78217

Sponsors and Collaborators

Opiant Pharmaceuticals Inc

Investigators

• Principal Investigator: Robert Bass, MD; Worldwide Clinical Trials

More Information

• Responsible Party: Opiant Pharmaceuticals Inc
• ClinicalTrials.gov Identifier: NCT04759768
• Other Study ID Numbers: OPNT003-PK-001
• First Posted: February 18, 2021
• Last Update Posted: October 22, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Naltrexone; Nalmefene; Narcotic Antagonists; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Alcohol Deterrents