Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

PHASE2CompletedINTERVENTIONAL
Enrollment

524

Participants

Timeline

Start Date

August 2, 2017

Primary Completion Date

June 14, 2021

Study Completion Date

June 28, 2021

Conditions
Acute Uncomplicated Plasmodium Falciparum Malaria
Interventions
DRUG

KAF156

KAF156 comes in 100 mg tablets for oral administration. KAF156 was administered in combination with LUM-SDF once daily (QD) for 1, 2 or 3 days at 200 mg, 400 mg or 800 mg doses.

DRUG

Coartem

Coartem comes as 20/120 mg dispersible tablets or 80/480 mg tablets for oral administration. Coartem was administered twice daily for 3 days as active comparator.

DRUG

Lumefantrine Solid Dispersion Formulation

LUM-SDF comes in 240 mg or 480 mg sachets for oral administration. LUM-SDF was administered in combination with KAF156 once daily (QD) for 1, 2 or 3 days at 480 mg or 960 mg doses.

Trial Locations (11)

2300

Novartis Investigative Site, Siaya

63140

Novartis Investigative Site, Tak

830000

Novartis Investigative Site, Binh Phuoc Province

834009

Novartis Investigative Site, Ranchi

Unknown

Novartis Investigative Site, Nanoro

Novartis Investigative Site, Lambaréné

Novartis Investigative Site, Kombewa

Novartis Investigative Site, Sotouba

Novartis Investigative Site, Chokwé

Novartis Investigative Site, Masaka

Novartis Investigative Site, Tororo

Sponsors
All Listed Sponsors
collaborator

Medicines for Malaria Venture

OTHER

lead

Novartis Pharmaceuticals

INDUSTRY