Naloxone Auto-injection in Healthy Volunteers

Study Overview
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Brief Summary
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This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West Pharmaceuticals, Inc. The SmartDose is a wearable self-injection device that can deliver a drug under the skin with a push of a button. Naloxone is a drug used to reverse the effects of opioid drugs in the body. This study will evaluate if the mobile application can wireless trigger the delivery of a small dose of naloxone to a healthy adult volunteer.

Official Title
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Naloxone Administration Via Auto-injection in Healthy Volunteers

Conditions
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Overdose Antidote

Intervention / Treatment
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* Combination Product: Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male/female volunteers >18 years No allergy to naloxone or ingredients in its formulation Ability to read and understand English Written informed consent obtained from subject Ability to comply with study requirements Exclusion Criteria: History of alcohol or substance abuse History of unusual pain sensitivity, lack of sensitivity History of chronic myofascial, inflammatory, neuropathic pain Chronic use of medication known to interfere with naloxone Pregnant women and nursing mothers Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise subject safety or the quality of the data (e.g., persons with liver disease, renal insufficiency/failure) Alcohol on the breath

Ages Eligible for Study
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Minimum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy adults<br>Healthy adults will receive 1.2 mg of naloxone hydrochloride injection solution, administered once via a wearable auto-injector, West Pharma SmartDose Generation I system. The respiratory sensing system under study is used to detect slowed breathing for the purpose of triggering the administration of the naloxone. | Combination Product: Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system<br>* 1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of slowed breathing that triggers the successful actuation of the auto-injector | Ability of the accelerometer-based system to detect slowed breathing and trigger the successful auto injection of medication | The participant breathes to 8 breaths per minute and the breath hold (15 - 30 seconds) triggers the auto-injector. This will take place over 1 -3 minutes. | 
| Plasma concentration of naloxone in blood samples | The concentration of naloxone in the plasma is measured by blood at two time points | Blood sampling at 3 and 8 minutes after the auto injector is triggered |