Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers

Summary

The study consists of two Phases with the first phase (Pilot Phase) divided into two sub phases.

In each study phase, subjects will be admitted to the clinical unit from 10 hours prior to the first drug administration on Day -1 until approximately 12 hours following the last study drug administration. Screening of alcohol and drugs of abuse will be performed before the first study drug administration. For female subjects, a pregnancy test will be performed before the first drug administration. Clinical nasal irritation rating and the Brief Smell Identification Test will be performed at screening.

Conditions

• Opioid Overdose

Interventions

DRUG

IM Naloxone Injection

Single 0.4 mg IM naloxone injection will be administered (1 mL of 0.4 mg/mL injection, into the gluteus maximus muscle using a 23-gauge needle).

DRUG

Naloxone Nasal Spray

Single 4 mg intranasal naloxone spray will be administered in one nostril (0.1 mL of 4 mg/0.1 mL spray, based on the prescribing information and approved Instructions for Use).

DRUG

Naloxone Nasal Swab

4 mg naloxone nasal swab administered in nostril

DRUG

Naloxone Nasal Swab

8 mg naloxone nasal swab administered in nostril

DRUG

Naloxone Nasal Swab

12 mg naloxone nasal swab administered in nostril

DRUG

Naloxone Nasal Swab

12.5 mg naloxone nasal swab administered in nostril

Sponsors & Collaborators

• Pocket Naloxone Corp

  lead INDUSTRY

Principal Investigators

• Sonnie Kim · Pocket Naloxone Corp

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-21

Primary Completion

2022-04-03

Completion

2022-04-11

FDA Drug

Yes

Countries

• Canada

Study Locations