Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Phase 1

Completed

• Conditions: Opioid-Related Disorders
• Interventions: Drug: Nalmefene

• Registration Number: NCT03129347
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Study Start: 2017-06-01
• Primary Completion: 2017-06-09
• Study Completion: 2017-07-03
• Status Verified: 2017-11
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nalmefene and Intravail	Nalmefene	Nalmefene (high dose) with Intravail intranasal one time during the 17 day inpatient treatment period
Nalmefene (high dose)	Nalmefene	Nalmefene (high dose) intranasal one time during the 17 day inpatient treatment period
Nalmefene (low dose)	Nalmefene	Nalmefene (low dose) intranasal one time during the 17 day inpatient treatment period
Nalmefene Intramuscular	Nalmefene	Nalmefene intramuscular one time during the 17 day inpatient treatment period

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of nalmefene	17 days	Maximum plasma concentration, time of Maximum observed concentration and area under the concentration-time curve

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vince and Associates Clinical Research; 🇺🇸 Overland Park, Kansas, United States