Clinical Trial: Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Brief Summary: This study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.

Detailed Summary: This study will be an inpatient, double-blind, randomized, crossover study involving 14 healthy volunteers. Each subject will receive 4 treatments during the 4 dosing periods.Subjects will stay in the inpatient facility for 17 days to complete the entire study and be discharged following completion of discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and concomitant medications since discharge. After obtaining informed consent, subject will be screened for eligibility. ON the day after clinic admission, subjects will be administered the intranasal-formulated drug in randomized order with 4 days between doses; the intramuscular dose will be administered during the fourth (last) treatment period.
Sponsor: National Institute on Drug Abuse (NIDA)

Current Primary Outcome:

  • Maximum Plasma Concentration (Cmax) [ Time Frame: 17 days ]
    Maximum plasma concentration, as observed by inspection of the individual study participant plots of plasma concentration versus time.
  • Time of Maximum observed concentration (Tmax) [ Time Frame: 17 days ]
    The time of maximum observed concentration, obtained directly from the observed concentration versus time data
  • Area under the concentration-time curve (AUC) [ Time Frame: 17 days ]
    The area under the concentration-time curve from time 0 (predose) to the time of the last quantifiable concentration, calculated by the linear-up/log-down trapezoidal method


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of Increased Vital Sign (Safety and Tolerability) [ Time Frame: 17 days ]
    Number of participants with treatment-related adverse events as assessed by vital signs
  • Incidence of Increased Blood Pressure (Safety and Tolerability) [ Time Frame: 17 days ]
    Number of participants with treatment-related adverse events as assessed by blood pressure
  • Incidence of Increased ECG Reading (Safety and Tolerability) [ Time Frame: 17 days ]
    Number of participants with treatment-related adverse events as assessed by ECG
  • Incidence of Clinically Significant Laboratory Values (Safety and Tolerability) [ Time Frame: 17 days ]
    Number of participants with treatment-related adverse events as assessed by clinical laboratory changes
  • Incidence of Nasal Irritation (Safety and Tolerability) [ Time Frame: 17 days ]
    Number of participants with treatment-related adverse events as assessed by nasal irritation


Original Secondary Outcome: Same as current

Information By: National Institute on Drug Abuse (NIDA)

Dates:
Date Received: April 19, 2017
Date Started: June 2017
Date Completion: September 2017
Last Updated: May 2, 2017
Last Verified: May 2017