A Phase II, Double-Blind, Parallel-Group, Randomized, Dose-Ranging Study Assessing the Antimalarial Activity and Safety of RBx 11160 Administered for 7 Days in Patients With Acute Uncomplicated Plasmodium Falciparum Malaria

Fecha de inicio: 1 de junio de 2006

Inclusion Criteria: * Male or female patients aged 13 to 65 years, inclusive. * Body weight \> 30 kg with no clinical evidence of severe malnutrition. * Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum parasites only. Initial parasite densities appropriate for inclusion will be between 1000 and 100,000 asexual parasites/microL blood. * Presence of fever (axillary temperature \> 37.5 °C or oral or rectal temperature \> 38 °C). * Female patients must be non-lactating and willing to use contraceptive methods during the study period. * Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse. If a patient is unable to provide informed consent in writing, a thumbprint to indicate consent in the presence of at least 1 witness is acceptable. If applicable, for adolescents providing written informed consent, assent should be obtained from the patient's legally accepted representative/guardian. * Willingness and ability to comply with the study protocol for the duration of the study. * Patient resides within a reasonable distance of the investigational site, so that attendance of all study visits and follow-up by medical staff are logistically feasible. Exclusion Criteria: * Patients presenting with a mixed infection (i.e., malaria due to more than 1 causative parasite). * Patients with severe malaria. * Any antimalarial treatment during 2 weeks prior to Screening, as assessed by medical history. * History of hypersensitivity or allergic reactions to artemisinins. * Patients who have been treated with RBx 11160 in any study. * Participation in any investigational drug study during the 30 days prior to Screening. * Electrocardiogram (ECG) abnormalities with clinical significance or relevance that require urgent management. These abnormalities include QTc interval \> 450 msec at Screening and cardiac conduction disorders, with the exception of right bundle branch block. * A female patient who is lactating or pregnant at Screening. * Gastrointestinal dysfunction that could alter absorption or motility (e.g., diarrhea defined as \> 3 episodes of watery stools in the previous 24 hours or patients who have had 3 episodes of vomiting within 24 hours prior to Screening). * Patients with known significant renal or hepatic impairment indicated by the following laboratory evaluations at Screening: Serum creatinine \> 1.5 x upper limit of normal (ULN). Aspartate transaminase \> 2.5 x ULN. Alanine transaminase \> 2.5 x ULN. Alkaline phosphatase \> 2.5 x ULN. Total bilirubin \> 1.5 x ULN. * Patients who have had a splenectomy. * Immunocompromised patients, patients receiving immunosuppressive agents, or patients with known human immunodeficiency virus (HIV) infection. (Screening for these conditions is not required for entry in the study.) * Evidence of clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric (e.g., depression, anxiety, psychosis, or schizophrenia) or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied). * Patients who have epilepsy or a history of convulsions.