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Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02750748
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

Brief Summary:
To determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Naltrexone Other: Intravail Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers
Study Start Date : July 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 4mg Intranasal Naltrexone
Administer one 0.1 mL spray of a 40 mg/mL solution in one nostril
Drug: Naltrexone
Experimental: 4mg Intranasal Naltrexone with Intravail
Administer 0.1 mL spray of a 40 mg/mL solution with 0.25% Intravail in one nostril
Drug: Naltrexone
Other: Intravail
Experimental: 2mg Intramuscular Naltrexone
Administer 2 mg formulation intramuscularly
Drug: Naltrexone
Experimental: 50mg Naltrexone
Administer 50mg formulation orally
Drug: Naltrexone



Primary Outcome Measures :
  1. Plasma Concentration (Cmax) [ Time Frame: 48 hours ]
    Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration

  2. Plasma Concentration (Tmax) [ Time Frame: 48 hours ]
    Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration

  3. Plasma Concentration (AUC 0-t) [ Time Frame: 48 hours ]
    Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration

  4. Plasma Concentration (AUC 0-inf) [ Time Frame: 48 hours ]
    Measurement of serum naltrexone prior to dosing and at times 2, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours after naltrexone administration


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Maximum of 18 days ]
    Will be reported from the start of the first session to follow-up visit

  2. Vital Signs [ Time Frame: 12 days ]
    Measured before and after naltrexone administration

  3. 12-lead electrocardiogram [ Time Frame: 12 days ]
    Measured before and after naltrexone administration

  4. Nasal Irritation Scoring [ Time Frame: 5 days ]
    Will be reported from the start of the first session to follow-up visit



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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:

  • Males and females 18 to 55 years of age, inclusive.
  • Provide written informed consent.
  • 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.
  • Male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration. Female subject of childbearing potential must agree to use an acceptable method of birth control throughout the study and for 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.
  • Participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.

Exclusion Criteria:

  • Please contact site 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): NCT02750748


Locations
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United States, Kansas
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Study Chair: Nora Chiang, PhD National Institute on Drug Abuse (NIDA)

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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT02750748     History of Changes
Other Study ID Numbers: Naltexone-Ph1a-002
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2016

Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents