This study explores the safety, pharmacodynamics and pharmacokinetics of THN201 a combination of donepezil and mefloquine to improve cognitive function in healthy male volunteers after impairment by a scopolamine challenge.
This is a double-blind, 3-arm, parallel group study of 15 days duration including a scopolamine challenge at D15. Healthy male subjects will receive daily doses of THN201 (donepezil 5 mg and mefloquine), donepezil 5 mg or placebo and one subcutaneous injection of scopolamine 0.5 mg on D15. Cognitive function, EEG and P300 will be assessed at baseline and before and after scopolamine challenge at D15. A final safety evaluation will be performed 2 weeks after the end of the treatment period. Pharmacokinetic assessments will be performed to obtain a time/concentration profile of donepezil and mefloquine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
152
CHU Bordeaux
Bordeaux, France
CHU Clermont Ferrand
Clermont-Ferrand, France
CHU Grenoble
Grenoble, France
CHU Lille
Lille, France
CHU Marseille
Pharmacodynamics: Cognitive function measured with the Cognitive Drug Research (CDR) test battery
Main variable: Power of attention is the sum of the speed scores (msec) from three tests: Simple Reaction Time, Choice Reaction Time, and Digital Vigilance. Low values indicate better performance
Time frame: 15 days
Safety Adverse events
Number of subjects with spontaneously reported treatment related adverse events
Time frame: 29 days
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Marseille, France
Biotrial
Rennes, France
CHU Toulouse
Toulouse, France