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The Evaluation of Safety and Tolerance of Commercially Available Naltrexone Administered Daily - Assessment for CBRN Operations (TEST CANADA)

NCT03879460 PHASE1 COMPLETED

The objective of this study is to evaluate the tolerance and safety of naltrexone while performing military specific tasks, and to assess plasma concentrations following naltrexone, administered orally at 50 mg per day for 7 days. The physical and mental/cognitive performance assessments will be conducted at various times prior, during and following drug administration. Daily blood draws will also be taken to assess blood levels of naltrexone and active metabolites for correlation to performance parameters associated with the Military Skill \& Tasked Based Fitness Test.

Details

Lead sponsorTimothy Smith
PhasePHASE1
StatusCOMPLETED
Enrolment15
Start dateMon Mar 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionSun Mar 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Canada