Naloxone Auto-injection in Healthy Volunteers

NCT05099614 | Completed Early Phase 1 FDA Drug FDA Device

• 2 other identifiers: STUDY000059441914873
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overdose Antidote

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Healthy adults

EXPERIMENTAL

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

Interventions

Naloxone hydrochloride injection solution, SmartDose wearable auto injector and mobile respiratory sensing system COMBINATION_PRODUCT

1.2 mg of naloxone hydrochloride is administered to healthy adults using the SmartDose wearable auto injector and the mobile respiratory sensing system.

Healthy adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• U.S. National Science Foundation: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Study Officials

• Jacob Sunshine, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: March 10, 2021
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)