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Completed

NCT Number: NCT03851731

Evaluation of Intranasal Naltrexone and Naloxone

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

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Naltrexone

Drug

Intranasal spray

Other names: Vivitrol

naloxone

Drug

Intranasal spray

Other names: Narcan

Naltrexol

Drug

Intranasal spray

Primary outcomes

  1. Pharmacokinetic parameter [maximum serum concentration - Cmax]

    Time frame: 12 days

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

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

    Time frame: 12 days

    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.

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

    Time frame: 12 days

    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.

Secondary outcomes

  1. Adverse Events

    Time frame: 15 days

    To assess and document any adverse events measures

  2. Vital Sign - Heart Rate

    Time frame: 12 days

    To assess and document heart rate before and after intranasal dosing

  3. Vital Sign - Blood pressure (diastolic)

    Time frame: 12 days

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

  4. Vital Sign - Blood pressure (systolic)

    Time frame: 12 days

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

  5. Vital Sign - Respiration Rate

    Time frame: 12 days

    To assess and document respiration rate before and after intranasal dosing

  6. Electrocardiogram

    Time frame: 12 days

    Twelve-lead ECGs performed according to standard procedures that will assess P wave, PR interval, QRS complex, ST segment, T wave and QT interval.

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Pharmacokinetic Evaluation of Intranasal Naltrexone and Naloxone Administered Separately and in Combination in Healthy Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 22, 2019
Registry last updated
Sep 14, 2020

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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