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

Novartis

Status and phase: Completed; Phase 2

Conditions: Cure Rate

Treatments: Drug: KAE609

Study type: Interventional

Funder types: Industry

Identifiers

NCT01860989

CKAE609X2202

Details and patient eligibility

About

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

Full description

the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study.

cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.

Enrollment: 11 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 4 patient groups

Cohort 1

Experimental group

Description:

6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose

Treatment:

Drug: KAE609

Drug: KAE609

Drug: KAE609

Drug: KAE609

Cohort 2

Experimental group

Description:

6-12 subjects with Plasmodium falciparum malaria will receive 150 mg KAE609 as a single dose

Treatment:

Drug: KAE609

Drug: KAE609

Drug: KAE609

Drug: KAE609

Cohort 3

Experimental group

Description:

6 to 12 subjects with Plasmodium falciparum malaria will receive 225 mg KAE609 as a single dose

Treatment:

Drug: KAE609

Drug: KAE609

Drug: KAE609

Drug: KAE609

Cohort4

Experimental group

Description:

6- 12 subjects with Plasmodium falciparum malaria will receive 300 mg KAE609 as a single dose

Treatment:

Drug: KAE609

Drug: KAE609

Drug: KAE609

Drug: KAE609