Evaluation of Intranasal Naltrexone and Naloxone

Study Overview
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Brief Summary
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This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.

Official Title
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Pharmacokinetic Evaluation of Intranasal Naltrexone and Naloxone Administered Separately and in Combination in Healthy Volunteers

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Drug: Naltrexone
* Drug: Naloxone
* Drug: Naltrexol


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. Body mass index (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. Agree to use a reliable double-barrier method of birth control from the start of screening until one week 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: 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone<br>Subject received a single intranasal dose of 2 mg naltrexone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered | Drug: Naltrexone<br>* Intranasal spray<br>* Other names: Vivitrol;|
| Experimental: Naloxone<br>Subject received a single intranasal dose of 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered | Drug: Naloxone<br>* Intranasal spray<br>* Other names: Narcan;|
| Experimental: Naltrexol<br>Subject received a single intranasal dose of a combination of 2 mg naltrexone and 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered | Drug: Naltrexol<br>* Intranasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter [maximum serum concentration - Cmax] | The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration [Cmax], of naltrexone and naloxone when administered and in combination. | 12 days | 
| Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t] | The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration time curve [AUCO-t] of naltrexone and naloxone when administered and in combination. | 12 days | 
| Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf] | The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration curve from zero to infinity [AUCO-inf] of naltrexone and naloxone when administered and in combination. | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | To assess and document any adverse events measures | 15 days | 
| Vital Sign - Heart Rate | To assess and document heart rate before and after intranasal dosing | 12 days | 
| Vital Sign - Blood pressure (diastolic) | To assess and document blood pressure (diastolic) before and after intranasal dosing | 12 days | 
| Vital Sign - Blood pressure (systolic) | To assess and document blood pressure (systolic) before and after intranasal dosing | 12 days | 
| Vital Sign - Respiration Rate | To assess and document respiration rate before and after intranasal dosing | 12 days | 
| Electrocardiogram | Twelve-lead ECGs performed according to standard procedures that will assess P wave, PR interval, QRS complex, ST segment, T wave and QT interval. | 12 days |