Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

This study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders
• Intervention / Treatment: Drug: Nalmefene

Detailed Description

This study will be an inpatient, double-blind, randomized, crossover study involving 14 healthy volunteers. Each subject will receive 4 treatments during the 4 dosing periods.Subjects will stay in the inpatient facility for 17 days to complete the entire study and be discharged following completion of discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and concomitant medications since discharge. After obtaining informed consent, subject will be screened for eligibility. ON the day after clinic admission, subjects will be administered the intranasal-formulated drug in randomized order with 4 days between doses; the intramuscular dose will be administered during the fourth (last) treatment period.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince and Associates Clinical Research

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Males and females 18 to 55 years of age
• Provide written informed consent
• Body Mass index (BMI) ranging from 18 to 32 kg/m2
• Adequate venous access
• No clinically significant concurrent medical conditions
• Males subjects must agree to use an acceptable method of birth of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration
• Female subjects of child bearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after completing the study. Oral contraceptives are prohibited
• Agree not to ingest alcohol, drinks containing xanthine >500 mg / day (e.g., Coca Cola, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study

Exclusion Criteria:

• Please contact the site for more information

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nalmefene (high dose); Nalmefene (high dose) intranasal one time during the 17 day inpatient treatment period	Drug: Nalmefene; Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene; Other Names: Selincro
Experimental: Nalmefene and Intravail; Nalmefene (high dose) with Intravail intranasal one time during the 17 day inpatient treatment period	Drug: Nalmefene; Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene; Other Names: Selincro
Experimental: Nalmefene (low dose); Nalmefene (low dose) intranasal one time during the 17 day inpatient treatment period	Drug: Nalmefene; Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene; Other Names: Selincro
Experimental: Nalmefene Intramuscular; Nalmefene intramuscular one time during the 17 day inpatient treatment period	Drug: Nalmefene; Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene; Other Names: Selincro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameters of nalmefene	Maximum plasma concentration, time of Maximum observed concentration and area under the concentration-time curve	17 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Measure by adverse events, vital signs, ECG, clinical laboratory changes and nasal irritation following the administration of nalmefene	17 days

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): June 9, 2017
• Study Completion (Actual): July 3, 2017

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 23, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Nalmefene
• Other Study ID Numbers: Nalmefene-Ph1a-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No