Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria

Inclusion Criteria:

1. Male and female patients ≥18 years of age for Part A, ≥12 years of age for Part Band 2 to <12 years of age for Part C at screening.

2. Patients must have acute uncomplicated P. falciparum malaria mono infection atscreening confirmed by a parasite count between 5,000 to 150,000 asexual parasitecount/μl of blood for P. falciparum for Part A and between 1,000 to 150,000 asexualparasite count/μl of blood for Parts B and C.

3. Patients in Part A must weigh between 40 kg and 90 kg. Patients in Part B must weighbetween 35 kg and 90 kg at screening. Patients in Part C must weigh at least 10 kgat screening.

4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; orhistory of fever during the previous 24 hours.

Exclusion Criteria:

1. Patients with signs and symptoms of severe/complicated malaria at screening or mixedPlasmodium infection (i.e., infection with more than one malaria species) atscreening

2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level < 8 g/dL), orknown chronic underlying disease such as sickle cell disease at screening

3. Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or Bvaccination in the last 3 months, known gallbladder or bile duct disease, acute orchronic pancreatitis. Clinical or laboratory evidence of any of the following atscreening:

• AST/ALT > 3 x the upper limit of normal range (ULN), regardless of the level oftotal bilirubin

• AST/ALT > 1.5 and ≤ 2 x ULN and total bilirubin is > ULN

• Total bilirubin > 2 x ULN, regardless of the level of AST/ALT

4. Any known/suspected immunosuppressive or immunodeficient condition, including humanimmunodeficiency virus (HIV) infection at screening.

5. Pregnant or nursing (lactating) women, women of child-bearing potential, defined asall women physiologically capable of becoming pregnant, unless they are usingmethods of effective contraception, and sexually active patients not willing topractice effective contraception.

6. History or current diagnosis of ECG abnormalities indicating significant risk ofsafety for patients participating in the study such as:

• Concomitant clinically significant cardiac arrhythmias, e.g., sustainedventricular tachycardia, and clinically significant second or third degree AVblock without a pacemaker

• History of familial long QT syndrome or known family history of Torsades dePointe.

• Resting heart rate (physical exam or 12 lead ECG) < 50 bpm

Other protocol-defined inclusion/exclusion criteria may apply.