Comparison of Naloxone Pharmacokinetics

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT03386591

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder	Drug: Naloxone Device: Mucosal atomization device and syringe Device: Narcan Device: Intramuscular Auto Injector	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This will be an inpatient open-label, randomized, 5-period, 5-treatment, 5-sequence, crossover study involving approximately 30 healthy subjects.This will be an inpatient open-label, randomized, 5-period, 5-treatment, 5-sequence, crossover study involving approximately 30 healthy subjects.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices

Actual Study Start Date :

Jan 3, 2018

Actual Primary Completion Date :

Feb 8, 2018

Actual Study Completion Date :

Mar 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mucosal Atomization (1 administration) One Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril)	Drug: Naloxone Comparing pharmacokinetics of naloxone Device: Mucosal atomization device and syringe Injection
Experimental: Mucosal Atomization (2 administrations) Two Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart	Drug: Naloxone Comparing pharmacokinetics of naloxone Device: Mucosal atomization device and syringe Injection
Experimental: Narcan 2mg One Intranasal administration of 2 mg naloxone using Narcan nasal spray	Drug: Naloxone Comparing pharmacokinetics of naloxone Device: Narcan Nasal Spray
Experimental: Narcan 4mg One Intranasal administration of 4 mg naloxone using Narcan nasal spray	Drug: Naloxone Comparing pharmacokinetics of naloxone Device: Narcan Nasal Spray
Experimental: Intramuscular auto injector One Intramuscular administration of 2 mg naloxone using Evzio auto-injector	Drug: Naloxone Comparing pharmacokinetics of naloxone Device: Intramuscular Auto Injector Intramuscular injection Other Names: Evzio

Outcome Measures

Primary Outcome Measures

Pharmacokinetic parameters of naloxone [11 days]
Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve

Secondary Outcome Measures

Safety Assessments [16 days]
Number of participants with AEs, vital signs, ECG, laboratory changes and nasal irritation following the administration of naloxone.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males and females 18 to 55 years of age, inclusive
Provide written informed consent
BMI ranging from 18 to 32 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 from the screening visit until 90 days after the last study drug administration
Female subjects of childbearing potential must agree to use an acceptable method of birth control from the start of screening until 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 or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study

Exclusion Criteria:

Contact site directly for more information

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vince and Associates Clinical Research	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Debra Kelsh, MD, Vince and Associates Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT03386591

Other Study ID Numbers:

Naloxone P1a-003

First Posted:

Dec 29, 2017

Last Update Posted:

Mar 9, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Opioid-Related Disorders

Naloxone

Study Results

No Results Posted as of Mar 9, 2018