A Phase 2, multi-center, randomized, open-label, dose escalation study to determine safety of single (QD) and multiple (3 QD) doses of KAE609, given to adults with uncomplicated Plasmodium falciparum malaria

ovartis Pharma AG0 sites150 target enrollmentDecember 20, 2017

ConditionsMalaria

Overview

No summary available.

Registry

who.int

Start Date

December 20, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•¿Male and female patients ¿ 18 years with a body weight ¿ 45 kg.
•¿Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa\-stained thick film.
•¿P. falciparum parasitaemia of 500 to 50 000 parasites/¿L.
•¿Axillary temperature ¿ 37\.5ºC or oral/tympanic/rectal temperature ¿ 38\.0ºC; or history of fever during the previous 24 hours.
•¿Written informed consent must be obtained before any study assessment is performed. If the patient is unable to write, then a witnessed consent according to local ethical standards is permitted.

•¿Mixed Plasmodiun infections.
•¿Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016 criteria (WHO 2016\).
•¿Known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis B or C (testing not required), known gallbladder or bile duct disease, acute or chronic pancreatitis.
•¿Clinical or laboratory evidence of any of the following:
•oAST/ALT \> 1\.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
•oAST/ALT \> 1\.0 and ¿ 1\.5 x ULN and total bilirubin is \> ULN
•oTotal bilirubin \> 2 x ULN, regardless of the level of AST/ALT
•¿History of photodermatitis/increased sensitivity to sun.
•¿Pregnant or nursing (lactating) women.
•¿Known disturbances of electrolyte balance, e.g. hypokalemia, hypocalcemia or hypomagnesemia.