Clinical Trial: A Double-Blind, Placebo-controlled Crossover Study of Repeat Rivastigmine Administration in Healthy Male Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-Blind, Placebo-controlled Crossover Study to Assess the Pharmacokinetic Profile and the Physiological and Behavioral Effects of Repeat Rivastigmine (Exelon®) Administration in Young Heal
Brief Summary:
Rivastigmine is a carbamate, approved by the FDA for the treatment of mild to moderate dementia associated with Alzheimer's and Parkinson's diseases. Studies conducted in the Israel Institute of Biological Research (IIBR) have yielded encouraging results in utilizing rivastigmine pre-treatment as an alternative to pyridostigmine in partially protecting against organophosphate poisoning, particularly protecting the central nervous system.
The target population for this indication may consist of otherwise healthy people (e.g. soldiers). Although the treatment regimen has not been established yet it is assumed, based on animal experiments, that rivastigmine is likely to be administered in repeated doses. In this setting, further evaluation of the drug's effects and pharmacokinetics in young healthy subjects is warranted.
The objectives of this study are: 1) To assess the safety and tolerability of repeated rivastigmine administration (1.5 mg and 3 mg) in young healthy male volunteers; 2) To determine the pharmacokinetic profile of rivastigmine (1.5 mg and 3 mg) following a single and multiple dose administrations; 3) To assess the extent of blood ChE inhibition following a single and multiple administrations of rivastigmine and 4) To correlate physiological and behavioral effects with blood rivastigmine concentrations and blood ChE inhibition in these subjects.
This double-blind, placebo-controlled study will be divided in 3 identical periods, preceded with a two-day initial training in performing cognitive performance tests. Each period will consist of in-house confinement for 5 days in which rivastigmine will be administered 5 times at an interval of 12 hours. During each period, each subject will receive either rivastigmine 1.5 mg X 5, or either rivastigmine 3.0 mg X 5 or p
Detailed Summary:
Sponsor: Tel-Aviv Sourasky Medical Center
Current Primary Outcome: Physiological effects,Objective and subjective symptoms, Cognitive Performance tests [ Time Frame: 5 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 4. Pharmacokinetic parameters (Cmax, Tmax, AUCT, AUCI ) determined from plasma rivastigmine concentrations,Blood cholinesterase inhibition [ Time Frame: 5 weeks ]
Original Secondary Outcome: Same as current
Information By: Tel-Aviv Sourasky Medical Center
Dates:
Date Received: October 30, 2007
Date Started: January 2009
Date Completion:
Last Updated: March 26, 2014
Last Verified: February 2008
