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 range
20 Years – 60 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Minimum Inhibitory Concentration (MIC) of KAE609
Timeframe: Up to Day 8 after a single dose of KAE609