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Comparison of Naloxone Pharmacokinetics

Primary Purpose

Opioid-use Disorder

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Naloxone

Mucosal atomization device and syringe

Narcan

Intramuscular Auto Injector

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

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

Inclusion Criteria:

Males and females 18 to 55 years of age, inclusive
Provide written informed consent
BMI ranging from 18 to 32 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
Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm from the screening visit until 90 days after the last study drug administration
Female subjects of childbearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after the last study drug administration. Oral contraceptives are prohibited
Agree not to ingest alcohol, drinks containing xanthine >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:

Contact site directly for more information

Sites / Locations

Vince and Associates Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Mucosal Atomization (1 administration)

Mucosal Atomization (2 administrations)

Narcan 2mg

Narcan 4mg

Intramuscular auto injector

Arm Description

One Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril)

Two Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart

One Intranasal administration of 2 mg naloxone using Narcan nasal spray

One Intranasal administration of 4 mg naloxone using Narcan nasal spray

One Intramuscular administration of 2 mg naloxone using Evzio auto-injector

Outcomes

Primary Outcome Measures

Pharmacokinetic parameters of naloxone

Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve

Secondary Outcome Measures

Safety Assessments

Number of participants with AEs, vital signs, ECG, laboratory changes and nasal irritation following the administration of naloxone.

Full Information

NCT ID

NCT03386591

First Posted

December 18, 2017

Last Updated

March 7, 2018

Sponsor

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03386591

Brief Title

Comparison of Naloxone Pharmacokinetics

Official Title

Comparison of Naloxone Pharmacokinetics Using Marketed Naloxone Devices

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

January 3, 2018 (Actual)

Primary Completion Date

February 8, 2018 (Actual)

Study Completion Date

March 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.

6. Conditions and Keywords

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

Opioid-use Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

This will be an inpatient open-label, randomized, 5-period, 5-treatment, 5-sequence, crossover study involving approximately 30 healthy subjects.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mucosal Atomization (1 administration)

Arm Type

Experimental

Arm Description

One Intranasal administration of 2 mL naloxone using a mucosal atomization device and syringe (1 mL/nostril)

Arm Title

Mucosal Atomization (2 administrations)

Arm Type

Experimental

Arm Description

Two Intranasal administrations of 2 mL naloxone using mucosal atomization device and syringe (1 mL/nostril) 2 minutes apart

Arm Title

Narcan 2mg

Arm Type

Experimental

Arm Description

One Intranasal administration of 2 mg naloxone using Narcan nasal spray

Arm Title

Narcan 4mg

Arm Type

Experimental

Arm Description

One Intranasal administration of 4 mg naloxone using Narcan nasal spray

Arm Title

Intramuscular auto injector

Arm Type

Experimental

Arm Description

One Intramuscular administration of 2 mg naloxone using Evzio auto-injector

Intervention Type

Drug

Intervention Name(s)

Naloxone

Intervention Description

Comparing pharmacokinetics of naloxone

Intervention Type

Device

Intervention Name(s)

Mucosal atomization device and syringe

Intervention Description

Injection

Intervention Type

Device

Intervention Name(s)

Narcan

Intervention Description

Nasal Spray

Intervention Type

Device

Intervention Name(s)

Intramuscular Auto Injector

Other Intervention Name(s)

Evzio

Intervention Description

Intramuscular injection

Primary Outcome Measure Information:

Title

Pharmacokinetic parameters of naloxone

Description

Maximum plasma concentration, time of maximum observed concentration and area under the concentration-time curve

Time Frame

11 days

Secondary Outcome Measure Information:

Title

Safety Assessments

Description

Number of participants with AEs, vital signs, ECG, laboratory changes and nasal irritation following the administration of naloxone.

Time Frame

16 days

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: Males and females 18 to 55 years of age, inclusive Provide written informed consent BMI ranging from 18 to 32 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 Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm from the screening visit until 90 days after the last study drug administration Female subjects of childbearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after the last study drug administration. Oral contraceptives are prohibited Agree not to ingest alcohol, drinks containing xanthine >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: Contact site directly for more information

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Debra Kelsh, MD

Organizational Affiliation

Vince and Associates Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vince and Associates Clinical Research

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Naloxone Pharmacokinetics

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