8
Participants
Start Date
June 30, 2014
Primary Completion Date
July 31, 2014
Study Completion Date
July 31, 2014
ACT-451840:
ACT-451840 500 mg was provided in 100 mL amber glass bottles formulated as a powder for oral suspension. The ACT-451840 suspension was prepared extemporaneously by addition of 25 mL of water and administered orally under fed condition.
Plasmodium falciparum-infected human erythrocytes:
Each participant was inoculated on Day 0 with approximately 1,800 viable Plasmodium falciparum-infected human erythrocytes administered intravenously.
Artemether 20 mg and lumefantrine 120mg combination tablet:
Rescue treatment to ensure clearance of Plasmodium falciparum comprising six doses of four tablets (total course of 24 tablets) given over a period of 60 hours. Each dose of tablets administered orally was immediately followed by food or drinks rich in fat (e.g., milk).
Primaquine:
Rescue treatment to ensure clearance of Plasmodium falciparum, to be taken as a single oral 45 mg dose with food only if gametocytes were identified after administration of Riamet® rescue medication.
Q-Pharm Clinics, Herston
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
INDUSTRY