Study to Investigate the Safety, Tolerability and Pharmacokinetics of AD 452 [(+)-Mefloquine] Compared With Racemic Mefloquine
NCT ID: NCT00931697
Last Updated: 2010-08-03
Study Results
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Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2009-06-30
2009-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AD 452 (+) mefloquine
AD 452 (+) mefloquine
Single dose delivered as over-encapsulated tablet at ascending doses
Racemic mefloquine
Racemic Mefloquine
Single dose delivered as over-encapsulated tablet at ascending dose
Placebo
Placebo
Over-encapsulated placebo to maintain blinding
Interventions
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AD 452 (+) mefloquine
Single dose delivered as over-encapsulated tablet at ascending doses
Racemic Mefloquine
Single dose delivered as over-encapsulated tablet at ascending dose
Placebo
Over-encapsulated placebo to maintain blinding
Eligibility Criteria
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Inclusion Criteria
* Negative urine drugs of abuse and breath alcohol test
* Willing to use double barrier contraception for 13 weeks after administration of study drug
Exclusion Criteria
* Existence of any surgical or medical condition which, in the judgement of the Principal Investigator, might interfere with the absorption and disposition of the drug or with the aim of the study including clinically significant lactose intolerance
* Receipt of prescription medication within 21 days of the first study day or over the counter medication (with the exception of multi-vitamins or paracetamol) within 1 week before the planned dosing date without prior approval
* Definite or suspected personal or family history of adverse drug reaction or hypersensitivity to drugs with a chemical structure similar to AD 452
* Participation in a clinical study within the previous 12 weeks
* A history of sensitivity to antimalarial or related compounds
* Definite or suspected personal or family history of adverse drug reaction or hypersensitivity to drugs with a chemical structure similar to AD 452
* Active depression or a recent history of depression or generalised anxiety disorder
* Any personal history of psychosis or schizophrenia or other major psychiatric disorders or convulsions
* Previous exposure to racemic mefloquine
18 Years
50 Years
ALL
Yes
Sponsors
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Medicines for Malaria Venture
OTHER
Treague Ltd
INDUSTRY
Responsible Party
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Treague Ltd
Principal Investigators
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Robert Tansley, MBBS
Role: STUDY_DIRECTOR
Treague Ltd
Locations
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LCG Bioscience
Cambridge, Cambridgeshire, United Kingdom
Countries
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Other Identifiers
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P-AD452-023
Identifier Type: -
Identifier Source: org_study_id
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