Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Drug Overdose Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2mg Intranasal Naloxone

Administer 0.1mL spray of the 20 mg/mL formulation in one nostril

Group Type EXPERIMENTAL

Naloxone

Intervention Type DRUG

4mg(a) Intranasal Naloxone

Administer 0.1mL spray of the 20 mg/mL formulation in both nostrils

Group Type EXPERIMENTAL

Naloxone

Intervention Type DRUG

4mg(b) Intranasal Naloxone

Administer 0.1mL spray of the 40mg/mL formulation in one nostril

Group Type EXPERIMENTAL

Naloxone

Intervention Type DRUG

8mg Intranasal Naloxone

Administer 0.1mL spray of the 40mg/mL formulation in both nostrils

Group Type EXPERIMENTAL

Naloxone

Intervention Type DRUG

Intramuscular Naloxone

Administer 1mL of 0.4mg/mL formulation intramuscularly

Group Type EXPERIMENTAL

Naloxone

Intervention Type DRUG

Interventions

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Naloxone

Intervention Type DRUG

Eligibility Criteria

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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.