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

Novartis Pharmaceuticals27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malaria

Interventions

KAE609DRUG

KAE609 was supplied as capsules for oral use.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (3)

Novartis Investigative Site

Bangkok, Thailand

Novartis Investigative Site

Tak, Thailand

Novartis Investigative Site

Tak Province, Thailand

Outcomes

Primary Outcomes

Parasite clearance time

Calculated based on parasite count in blood. In thin film, use actual WBCs/µl, of blood to calculate parasite density by using the following formula: parasites/µl= #parasites× actual WBC/#WBCs counted. In thick film, assume that there are 250 RBCs per HPF, RBC count from 8 HPF equal 2000 RBC, Use actual RBCs/µl blood to calculate parasite density by using the following formula: parasites/µl= # of parasites in 8HPF/2000)× actual RBC.

Time frame: From baseline to the time point when the blood parasite count is zero(up to a maximum of 5 days)

Secondary Outcomes

Number of participants with adverse events

Number of participants with adverse events determined by Vital sign(body temperature, blood pressure and pulse rate): pre dose, 4, 8, 12, 16, 20, 24 hours post dose on Day 1: then 6, 12, 18, 24 hours post dose on each day during domiciles period until at least two consecutive normal temperature readings are obtained, then it will measure daily until Day 6. ECG: 3-4 hours post dose on day1; pre dose, 3-4 hours post dose on Day 2; pre dose, 3-4 hours post dose on Day 3 and study completion. Lab evaluation: Day 2, Day3 and Day5, study completion.

Time frame: vital signs: Days 1 through 6; ECG: Days1, 2, 3; Labs: Days 2, 3, 5, study completion

Area under the curve (AUC)0-24h on Day 1 and Day 3

The parent drug in plasma samples will be analyzed. On Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. \*The 24h sampling of first post dose should be taken before the second dose. On Day 3: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, and 192 hours post dose

Time frame: Day 1 and Day 3

The accumulation ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1)

Data from ClinicalTrials.gov

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