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

Novartis

Status and phase: Completed; Phase 2

Conditions: Malaria

Treatments: Drug: KAE609

Study type: Interventional

Funder types: Industry

Identifiers

NCT01836458

CKAE609A2201

Details and patient eligibility

About

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

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 4 patient groups

Dose 1: 30 mg

Experimental group

Description:

Single dose of KAE609 30 mg

Treatment:

Drug: KAE609

Dose 2: 20 mg

Experimental group

Description:

Single dose of KAE609 20 mg

Treatment:

Drug: KAE609

Dose 3: 10 mg

Experimental group

Description:

Single dose of KAE609 10 mg

Treatment:

Drug: KAE609

Dose 4: 15 mg

Experimental group

Description:

Single dose of KAE609 15 mg

Treatment:

Drug: KAE609