Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

Novartis

Status and phase: Completed; Phase 2

Conditions: Malaria

Treatments: Drug: KAE609

Study type: Interventional

Funder types: Industry

Identifiers

NCT01524341

CKAE609X2201

Details and patient eligibility

About

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day

Enrollment: 27 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients aged 20 to 60 years
• Presence of mono-infection of P. falciparum or P. vivax
• 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

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Cohort 1

Experimental group

Description:

10 subjects with Plasmodium vivax malaria will receive 30 mg KAE609 once a day for three days

Treatment:

Drug: KAE609

Cohort 2

Experimental group

Description:

10 subjects with Plasmodium falciparum malaria will receive 30 mg KAE609 once a day for three days

Treatment:

Drug: KAE609