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Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

Primary Purpose

Drug Overdose, Opioid-Related Disorders

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Naloxone

About this trial

This is an interventional treatment trial for Drug Overdose

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Vince Associates Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

2mg Intranasal Naloxone

4mg(a) Intranasal Naloxone

4mg(b) Intranasal Naloxone

8mg Intranasal Naloxone

Intramuscular Naloxone

Arm Description

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

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

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

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

Administer 1mL of 0.4mg/mL formulation intramuscularly

Outcomes

Primary Outcome Measures

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 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

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

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

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

Secondary Outcome Measures

Adverse events

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

Vital Signs

Measured at pre-dose and at times 30 , 60, 120 and 480 minutes after naloxone administration.

12-lead electrocardiogram

Measured at pre-dose and at times 60 and 480 minutes after naloxone administration.

Nasal Irritation Scoring

Measured at pre-dose and at times 5, 30 , 60, 240 minutes and 24 hours after nasal naloxone administration.

Full Information

NCT ID

NCT02572089

First Posted

October 5, 2015

Last Updated

January 11, 2017

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Vince & Associates Clinical Research, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02572089

Brief Title

Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

Vince & Associates Clinical Research, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Overdose, Opioid-Related Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2mg Intranasal Naloxone

Arm Type

Experimental

Arm Description

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

Arm Title

4mg(a) Intranasal Naloxone

Arm Type

Experimental

Arm Description

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

Arm Title

4mg(b) Intranasal Naloxone

Arm Type

Experimental

Arm Description

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

Arm Title

8mg Intranasal Naloxone

Arm Type

Experimental

Arm Description

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

Arm Title

Intramuscular Naloxone

Arm Type

Experimental

Arm Description

Administer 1mL of 0.4mg/mL formulation intramuscularly

Intervention Type

Drug

Intervention Name(s)

Naloxone

Primary Outcome Measure Information:

Title

Maximum Plasma Concentration (Cmax)

Description

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

Title

Time at Maximum Plasma Concentration (Tmax)

Description

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

Title

Area Under the Concentration (AUC 0-t)

Description

Time Frame

720 minutes

Title

Area Under Curve (AUC 0-inf)

Description

Time Frame

720 minutes

Title

Half-life

Description

Time Frame

720 minutes

Secondary Outcome Measure Information:

Title

Adverse events

Description

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

Time Frame

minimum of 18 days

Title

Vital Signs

Description

Measured at pre-dose and at times 30 , 60, 120 and 480 minutes after naloxone administration.

Time Frame

480 minutes

Title

12-lead electrocardiogram

Description

Measured at pre-dose and at times 60 and 480 minutes after naloxone administration.

Time Frame

480 minutes

Title

Nasal Irritation Scoring

Description

Measured at pre-dose and at times 5, 30 , 60, 240 minutes and 24 hours after nasal naloxone administration.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Vince Associates Clinical Research

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

12. IPD Sharing Statement

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Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

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