Status:
COMPLETED
Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Malaria
Eligibility:
All Genders
20-60 years
Phase:
PHASE2
Brief Summary
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day
Eligibility Criteria
Inclusion
- Male and female patients aged 20 to 60 years
- Presence of mono-infection of P. falciparum or P. vivax
- Weight between 40 kg to 90 kg
Exclusion
- Patients with signs and symptoms of severe/complicated malaria
- Mixed Plasmodium infection
- Presence of other serious or chronic clinical condition requiring hospitalization.
- Severe malnutrition
- Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01524341
Start Date
January 1 2012
End Date
June 1 2012
Last Update
May 13 2013
Active Locations (3)
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1
Novartis Investigative Site
Bangkok, Thailand, 10400
2
Novartis Investigative Site
Tak, Thailand, 63110
3
Novartis Investigative Site
Tak Province, Thailand, 63110