Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Itraconazole

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

November 18, 2021

Primary Completion Date

May 13, 2022

Study Completion Date

May 14, 2022

Conditions
Malaria
Interventions
DRUG

Ganaplacide

Treatment A/Period 1: 400 mg (4 x 100 mg tablets) at Hour 0 on Day 1 Treatment B/Period 2: 400 mg (4 x 100 mg tablets) at Hour 0, approximately 2 hours after itraconazole dosing, on Day 5.

COMBINATION_PRODUCT

Lumefantrine

Treatment A/Period 1: 480 mg (2 x 240 mg sachets) at Hour 0 on Day 1 Treatment B/Period 2: 480 mg (2 x 240 mg sachets) at Hour 0, approximately 2 hours after itraconazole dosing, on Day 5.

DRUG

Itraconazole

200 mg (20 mL of 10 mg/mL oral solution) q.d. on Days 1 to 18

Trial Locations (1)

BT9 6AD

Novartis Investigative Site, Belfast

Sponsors
All Listed Sponsors
collaborator

Medicines for Malaria Venture

OTHER

lead

Novartis Pharmaceuticals

INDUSTRY