A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
NCT ID: NCT01860989
Last Updated: 2015-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
11 participants
INTERVENTIONAL
2013-07-31
2014-08-31
Brief Summary
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Detailed Description
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cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
KAE609
KAE609 75mg single dose
Cohort 2
6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose
KAE609
KAE609 150mg single dose
Cohort 3
6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose
KAE609
KAE609 225mg single dose
Cohort4
6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose
KAE609
KAE609 300mg single dose
Interventions
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KAE609
KAE609 75mg single dose
KAE609
KAE609 150mg single dose
KAE609
KAE609 225mg single dose
KAE609
KAE609 300mg single dose
Eligibility Criteria
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Inclusion Criteria
* Presence of mono-infection of P. falciparum
* Weight between 40 kg to 90 kg
Exclusion Criteria
* 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
20 Years
60 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Ratchabari, , Thailand
Novartis Investigative Site
Si Sa Ket, , Thailand
Novartis Investigative Site
Tak, , Thailand
Novartis Investigative Site
Hanoi, , Vietnam
Countries
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Other Identifiers
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CKAE609X2202
Identifier Type: -
Identifier Source: org_study_id
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