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Completed

NCT Number: NCT02572089

Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers

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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Key information

Conditions

Drug Overdose Chemically-Induced Disorders Drug Misuse Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vince Associates Clinical Research

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

naloxone

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • Vince & Associates Clinical Research, Inc.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2015
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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