Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Conditions
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Opioid-Related Disorders

Intervention / Treatment
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* Drug: Nalmefene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |