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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: National Institute on Drug Abuse (NIDA)

Current Primary Outcome:

  • 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
  • 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
  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse Events [ Time Frame: Maximum of 18 days ]
    Will be reported from the start of the first session to follow-up visit
  • Vital Signs [ Time Frame: 12 days ]
    Measured before and after naltrexone administration
  • 12-lead electrocardiogram [ Time Frame: 12 days ]
    Measured before and after naltrexone administration
  • Nasal Irritation Scoring [ Time Frame: 5 days ]
    Will be reported from the start of the first session to follow-up visit


Original Secondary Outcome: Same as current

Information By: National Institute on Drug Abuse (NIDA)

Dates:
Date Received: April 21, 2016
Date Started: July 2016
Date Completion:
Last Updated: January 11, 2017
Last Verified: October 2016