A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Fal… (NCT01836458) | Clinical Trial Compass
CompletedPhase 2
A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection
Vietnam25 participantsStarted 2014-01
Plain-language summary
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
Who can participate
Age range20 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Monoinfection with P. falciparum confirmed by microscopy
* Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
* Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
* Body weight between 40 to 90 kg
Key Exclusion Criteria:
* Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
* Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
* Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
* History of antimalarial use within 2 months of screening
* Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
* Long QT syndrome or QTc using Fridericia's formula \>430 msec
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
* Hemoglobin level \<10 g/dL
* Liver disease or injury as indicated by elevated liver tests such as SGPT (ALT) or SGOT (AST) \>2 times the upper limit of normal
* Renal dysfunction as indicated by serum creatinine \>2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be \<2 times the upper limit of normal after oral or parental rehyd…
What they're measuring
1
Minimum Inhibitory Concentration (MIC) of KAE609
Timeframe: Up to Day 8 after a single dose of KAE609