Status:
COMPLETED
Study to Investigate the Safety, Tolerability and Pharmacokinetics of AD 452 [(+)-Mefloquine] Compared With Racemic Mefloquine
Lead Sponsor:
Treague Ltd
Collaborating Sponsors:
Medicines for Malaria Venture
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 marke...
Eligibility Criteria
Inclusion
- A BMI of between 19 and 28
- Negative urine drugs of abuse and breath alcohol test
- Willing to use double barrier contraception for 13 weeks after administration of study drug
Exclusion
- Pregnant or lactating females
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00931697
Start Date
June 1 2009
End Date
November 1 2009
Last Update
August 3 2010
Active Locations (1)
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1
LCG Bioscience
Cambridge, Cambridgeshire, United Kingdom, CB23 2TN