Pharmacokinetic Drug-Drug Interaction Study

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

December 31, 2014

Study Completion Date

January 31, 2015

Conditions
Chagas Disease
Interventions
DRUG

Benznidazole

Benznidazole single dose (2.5 mg/kg) at Day 1. Benznidazole single dose (2.5 mg/kg) at Day 9\*. Benznidazole multiple dose (2.5 mg/kg twice daily) from Day 12\* until Day 15.

DRUG

E1224

"E1224 multiple dose 400 mg loading dose once daily for 3 days (i.e. from Day 4 to Day 6 followed by maintenance dose 100mg once daily for 9 days (from Day 7 to Day15).~On Day 9 and from Day 12 to Day 15, E1224 and benznidazole will be given concomitantly."

Trial Locations (1)

C1425BAB

FP Clinical Pharma - Juncal 4484 - 3o piso, Buenos Aires

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PhinC Development

INDUSTRY

lead

Drugs for Neglected Diseases

OTHER