Evaluation of Intranasal Naltrexone and Naloxone

National Institute on Drug Abuse (NIDA)12 enrolled

Overview

This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Opioid-use Disorder

Interventions

NaltrexoneDRUG

Intranasal spray

NaloxoneDRUG

Intranasal spray

NaltrexolDRUG

Intranasal spray

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females 18 to 55 years of age, inclusive. * Provide written informed consent. * Body mass index (BMI) ranging from 18 to 30 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. * 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. * Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, tea, coffee, 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 for more information

Outcomes

Primary Outcomes

Pharmacokinetic parameter [maximum serum concentration - Cmax]

The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration \[Cmax\], of naltrexone and naloxone when administered and in combination.

Time frame: 12 days

Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t]

The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration time curve \[AUCO-t\] of naltrexone and naloxone when administered and in combination.

Time frame: 12 days

Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf]

The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration curve from zero to infinity \[AUCO-inf\] of naltrexone and naloxone when administered and in combination.

Time frame: 12 days

Secondary Outcomes

Adverse Events

To assess and document any adverse events measures

Time frame: 15 days

Vital Sign - Heart Rate

To assess and document heart rate before and after intranasal dosing

Time frame: 12 days

Vital Sign - Blood pressure (diastolic)

To assess and document blood pressure (diastolic) before and after intranasal dosing

Time frame: 12 days

Vital Sign - Blood pressure (systolic)

To assess and document blood pressure (systolic) before and after intranasal dosing

Data from ClinicalTrials.gov

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