Status:
COMPLETED
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cure Rate
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 acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/...
Detailed Description
the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study. cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg...
Eligibility Criteria
Inclusion
- Male and female patients aged 20 to 60 years
- Presence of mono-infection of P. falciparum
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01860989
Start Date
July 1 2013
End Date
August 1 2014
Last Update
September 10 2015
Active Locations (4)
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1
Novartis Investigative Site
Ratchabari, Thailand, 70180
2
Novartis Investigative Site
Si Sa Ket, Thailand, 33140
3
Novartis Investigative Site
Tak, Thailand, 63140
4
Novartis Investigative Site
Hanoi, Vietnam, 10000