Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

Novartis

Status and phase: Completed; Phase 2

Conditions: Malaria

Treatments: Drug: KAF156

Study type: Interventional

Funder types: Industry

Identifiers

NCT01753323

CKAF156X2201

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 KAF156 at 400 mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)

Enrollment: 43 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
• Infection with more than one parasite species
• Women of child-bearing potential; pregnant or nursing women
• Those who have taken any anti-malarial treatment in the preceding 14 days or other investigational drugs within 30 days or 5 half-lives

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 3 patient groups

Part 1 - Cohort 1: P. vivax: KAF156 400mg QD

Experimental group

Description:

Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.

Treatment:

Drug: KAF156

Part 1 - Cohort 2: P. falciparum: KAF156 400mg QD

Experimental group

Description:

Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.

Treatment:

Drug: KAF156

Part 2 - Cohort 3: P. falciparum: KAF156 800mg single dose

Experimental group

Description:

Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.

Treatment:

Drug: KAF156