This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609
There will be a total of approximately 45 patients recruited into this study and six doses of KAE609 and will be investigated.The dose groups will run in sequence. Patient will be given a single dose of KAE609 and be followed up for 42 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Patients will receive KAE609 single dose at a different dose level in each cohort.
Novartis Investigative Site
Ho Chi Minh City, Vietnam
Minimum Inhibitory Concentration (MIC) of KAE609
To observe the exposure-response (PK/PD) relationship for a single dose of KAE609. The key parameter is MIC, defined as the concentration at which the relative rate of change in parasitemia is equal to zero. Approximation of MIC will assist in identifying the optimal dose of KAE609, which will be one component of a future combination antimalarial. MIC could not be determined due to small sample size no data was collected from any participants.
Time frame: Up to Day 8 after a single dose of KAE609
Median Time to Parasite Clearance
Parasite clearance time will be estimated using thick/thin blood films.
Time frame: pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, 54, 60, 66, 72 hours post dose of KAE609
Median Time to Fever Clearance
Fever is monitored on participants every 4 hours for the first 24 hours, then every 6 hours until negative reading obtained.
Time frame: Day 1 to Day 5
Percentage of Patients PCR-corrected Cure Rate by Day 28, Day 35 & Day 42
PCR-corrected cure rate after a single dose of KAE609 by Day 28, Day 35 \& Day 42. PCR-corrected cure rate accounts for failures due to reappearance of parasites that were present in the blood before treatment (i.e. recrudescent infection) but not for failures due to a post-treatment inoculation (i.e. new infection).
Time frame: Day 28, Day 35 & Day 42
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