Healthy Subjects Clinical Trial
Official title:
A Phase I Randomised, Double-Blind Study to Investigate the Safety, Tolerability and Pharmacokinetics of AD 452 [(+)-Mefloquine] Compared With Racemic Mefloquine
Mefloquine is a quinolinemethanol antimalarial that is effective as therapy and prophylaxis
for all species of malaria infecting humans, including multi-drug resistant Plasmodium
falciparum. The marketed anti-malaria drug consists of two enantiomers of mefloquine.
Mefloquine's clinical utility has been impaired by its association with neuropsychiatric
side effects. The pharmacological basis of mefloquine's side effects is not known but two of
the most reported hypotheses relate to its action on (i) the adenosine receptor and (ii) its
effect on the cholinesterase enzyme. For both of these mechanisms, there is a significant
stereoselective activity of the two enantiomers. In vitro studies show that the (-) isomer
is 50-100 fold more potent towards adenosine receptors compared with the (+) isomer. In
addition, (-)-mefloquine has considerably more anti-cholinesterase activity. It has
therefore been hypothesised that (+)-mefloquine may have a better central nervous system
(CNS) safety profile compared with either the racemate or (-)-mefloquine.
This study is a randomized, ascending dose, double-blind, active and placebo-controlled,
parallel group study in healthy male and female volunteers designed to investigate this
hypothesis and to describe the comparative pharmacokinetics of the racemate and the single
enantiomer.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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