A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Male and female patients aged 20 to 60 years

• Presence of mono-infection of P. falciparum

• Weight between 40 kg to 90 kg

Exclusion Criteria:

• Patients with signs and symptoms of severe/complicated malaria

• Mixed Plasmodium infection

• Presence of other serious or chronic clinical condition requiring hospitalization.

• Severe malnutrition

• Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study