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

Exclusion Criteria

• •1. Patients with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening
• •2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \< 8 g/dL), or known 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 B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:
• •* AST/ALT \> 3 x the upper limit of normal range (ULN), regardless of the level of total 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 human immunodeficiency virus (HIV) infection at screening.
• •5. Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception.
• •6. History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:
• •* Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
• •* History of familial long QT syndrome or known family history of Torsades de Pointe.
• •* Resting heart rate (physical exam or 12 lead ECG) \< 50 bpm