Pharmacokinetic Evaluation of Intranasal Nalmefene

• Sponsor: Opiant Pharmaceuticals Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04759768
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 19.7

Study Details

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
• 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: Feb 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) [48 hours]

   Maximum concentration of plasma nalmefene comparing IN to IM

2. Time to maximum plasma concentration (Tmax) [48 hours]

   Time to maximum concentration of plasma nalmefene comparing IN to IM

3. Area under the curve (AUC) [48 hours]

   Area under the curve of plasma nalmefene comparing IN to IM

4. Half-life (t1/2) [48 hours]

   Half life of plasma nalmefene comparing IN to IM

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	Worldwide Clinical Trials	San Antonio	Texas	United States	78217

Sponsors and Collaborators

• Opiant Pharmaceuticals Inc

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Opiant Pharmaceuticals Inc
• ClinicalTrials.gov Identifier: NCT04759768
• Other Study ID Numbers: OPNT003-PK-001
• First Posted: Feb 18, 2021
• Last Update Posted: Oct 22, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Oct 22, 2021