CompletedPhase 2

Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

Thailand, Vietnam43 participantsStarted 2013-03

Plain-language summary

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400 mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)

Who can participate

Age range20 Years – 60 Years

SexALL

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Inclusion criteria

✓Male and female patients aged 20 to 60 years;Presence of mono-infection of P. falciparum or P. vivax; Weight between 40 kg to 90 kg.

What they're measuring

Time to Parasite Clearance

Timeframe: Day 5

28-day Cure Rate - Part 2

Timeframe: Day 28

Trial details

NCT IDNCT01753323

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-08

Results submitted2015-07-23

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