Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers

Study Overview
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Brief Summary
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To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.

Official Title
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Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers

Conditions
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Opioid-Related Disorders

Intervention / Treatment
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* Drug: Naltrexone
* Other: Intravail


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females 18 to 55 years of age, inclusive. Provide written informed consent. BMI ranging from 18 to 30 kg/m2, inclusive. Adequate venous access. No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG. Male subjects must agree to use an acceptable method 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 subject of childbearing potential must agree to use an acceptable method of birth control throughout the study and for 30 days after the last study drug administration. Oral contraceptives are prohibited. Agree not to ingest alcohol, drinks containing xanthine >500 mg/day (e.g., Coca Cola®, coffee, tea, etc.), or grapefruit/grapefruit juice. Participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study. Exclusion Criteria: Please contact 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4mg Intranasal Naltrexone<br>Administer one 0.1 mL spray of a 40 mg/mL solution in one nostril | Drug: Naltrexone<br> <br> |
| Experimental: 4mg Intranasal Naltrexone with Intravail<br>Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril | Drug: Naltrexone<br> <br> Other: Intravail<br> <br> |
| Experimental: 2mg Intramuscular Naltrexone<br>Administer 2 mg formulation intramuscularly | Drug: Naltrexone<br> <br> |
| Experimental: 50mg Naltrexone<br>Administer 50mg formulation orally | Drug: Naltrexone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration (Cmax) | Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration | 48 hours | 
| Plasma Concentration (Tmax) | Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration | 48 hours | 
| Plasma Concentration (AUC 0-t) | Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration | 48 hours | 
| Plasma Concentration (AUC 0-inf) | Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Will be reported from the start of the first session to follow-up visit | Maximum of 18 days | 
| Vital Signs | Measured before and after naltrexone administration | 12 days | 
| 12-lead electrocardiogram | Measured before and after naltrexone administration | 12 days | 
| Nasal Irritation Scoring | Will be reported from the start of the first session to follow-up visit | 5 days |