Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

Opioid-Related Disorders Clinical Trial

Official title:

Phase 1, Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572089
• Other study ID #: Naloxone-Phase1a-002
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2015
• Last updated: January 11, 2017
• Start date: October 2014
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Be able to provide written consent

• Must have a BMI ranging from 18 to 30kg/m2, inclusive

• Must have adequate venous access

• Must not have any clinically significant concurrent medical conditions determine by medical history, physical examination, vital signs, and 12-lead electrocardiogram.

• Must agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.

• Must agree to not ingest alcohol, drinks containing xanthine greater than 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:

• Please contact clinical site directly for more information

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Overdose
• Opioid-Related Disorders

Intervention

Drug:
• Naloxone

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Vince & Associates Clinical Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax)	Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration.	720 minutes	No
Primary	Time at Maximum Plasma Concentration (Tmax)	Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration	720 minutes	No
Primary	Area Under the Concentration (AUC 0-t)	Time curve from time zero to last measurable concentration. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration	720 minutes	No
Primary	Area Under Curve (AUC 0-inf)	Time curve from time zero to infinity. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration	720 minutes	No
Primary	Half-life	The apparent terminal exponential half-life. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration	720 minutes	No
Secondary	Adverse events	will be reported from the start of the first session to the follow-up visit	minimum of 18 days	Yes
Secondary	Vital Signs	Measured at pre-dose and at times 30 , 60, 120 and 480 minutes after naloxone administration.	480 minutes	Yes
Secondary	12-lead electrocardiogram	Measured at pre-dose and at times 60 and 480 minutes after naloxone administration.	480 minutes	Yes
Secondary	Nasal Irritation Scoring	Measured at pre-dose and at times 5, 30 , 60, 240 minutes and 24 hours after nasal naloxone administration.	24 hours	Yes