A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cisplatin; Ifosfamide; Mitomycin

Criteria

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 rehydration

• Known to be immunocompromised (including HIV infection) or are receiving immunosuppressive therapy at the time or enrollment; HIV testing is not required

• Known history of hepatitis B or C; testing is not required

• Febrile condition due to diseases other than malaria (e.g. acute lower respiratory tract infection), known underlying chronic or severe disease (e.g. cardiac, hepatic, renal, gastrointestinal, neurologic, or psychiatric disease), or any condition precluding enrollment into this study according to the investigator

• Severe vomiting defined as >3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours

• Severe malnutrition defined by a body mass index (BMI) <18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting

• Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening