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Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572089
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Vince & Associates Clinical Research, Inc.
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Drug Overdose Opioid-Related Disorders Drug: Naloxone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 2mg Intranasal Naloxone
Administer 0.1mL spray of the 20 mg/mL formulation in one nostril
Drug: Naloxone
Experimental: 4mg(a) Intranasal Naloxone
Administer 0.1mL spray of the 20 mg/mL formulation in both nostrils
Drug: Naloxone
Experimental: 4mg(b) Intranasal Naloxone
Administer 0.1mL spray of the 40mg/mL formulation in one nostril
Drug: Naloxone
Experimental: 8mg Intranasal Naloxone
Administer 0.1mL spray of the 40mg/mL formulation in both nostrils
Drug: Naloxone
Experimental: Intramuscular Naloxone
Administer 1mL of 0.4mg/mL formulation intramuscularly
Drug: Naloxone



Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: 720 minutes ]
    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.

  2. Time at Maximum Plasma Concentration (Tmax) [ Time Frame: 720 minutes ]
    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

  3. Area Under the Concentration (AUC 0-t) [ Time Frame: 720 minutes ]
    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

  4. Area Under Curve (AUC 0-inf) [ Time Frame: 720 minutes ]
    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

  5. Half-life [ Time Frame: 720 minutes ]
    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 :
  1. Adverse events [ Time Frame: minimum of 18 days ]
    will be reported from the start of the first session to the follow-up visit

  2. Vital Signs [ Time Frame: 480 minutes ]
    Measured at pre-dose and at times 30 , 60, 120 and 480 minutes after naloxone administration.

  3. 12-lead electrocardiogram [ Time Frame: 480 minutes ]
    Measured at pre-dose and at times 60 and 480 minutes after naloxone administration.

  4. Nasal Irritation Scoring [ Time Frame: 24 hours ]
    Measured at pre-dose and at times 5, 30 , 60, 240 minutes and 24 hours after nasal naloxone administration.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572089


Locations
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United States, Kansas
Vince Associates Clinical Research
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Vince & Associates Clinical Research, Inc.
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT02572089    
Other Study ID Numbers: Naloxone-Phase1a-002
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2015
Additional relevant MeSH terms:
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Opioid-Related Disorders
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents