Effect of ACT-451840 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Healthy Subjects
Interventions
DRUG

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.

OTHER

Plasmodium falciparum-infected human erythrocytes:

Each participant was inoculated on Day 0 with approximately 1,800 viable Plasmodium falciparum-infected human erythrocytes administered intravenously.

DRUG

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).

DRUG

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.

Trial Locations (1)

4006

Q-Pharm Clinics, Herston

Sponsors
All Listed Sponsors
lead

Idorsia Pharmaceuticals Ltd.

INDUSTRY