Comparison of Naloxone Pharmacokinetics

Opioid-use Disorder Clinical Trial

Official title:

Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386591
• Other study ID #: Naloxone P1a-003
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2017
• Last updated: March 7, 2018
• Start date: January 3, 2018
• Est. completion date: March 6, 2018

Study information

• Verified date: March 2018
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 6, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-use Disorder

Intervention

Drug:
• Naloxone
Comparing pharmacokinetics of naloxone

Device:
• Mucosal atomization device and syringe
Injection
• Narcan
Nasal Spray
• Intramuscular Auto Injector
Intramuscular injection

Locations

Country	Name	City	State
United States	Vince and Associates Clinical Research	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters of naloxone	Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve	11 days
Secondary	Safety Assessments	Number of participants with AEs, vital signs, ECG, laboratory changes and nasal irritation following the administration of naloxone.	16 days