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