Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

Phase 1CompletedNCT02572089

National Institute on Drug Abuse (NIDA)30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug Overdose Opioid-Related Disorders

Interventions

NaloxoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Vince Associates Clinical Research

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: 720 minutes

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

Time frame: 720 minutes

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

Time frame: 720 minutes

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

Time frame: 720 minutes

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

Time frame: 720 minutes

Secondary Outcomes

Adverse events

will be reported from the start of the first session to the follow-up visit

Time frame: minimum of 18 days

Vital Signs

Data from ClinicalTrials.gov

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