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

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

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Key information

Conditions

Cure Rate Infections Inflammation Parasitemia Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Ratchabari, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KAE609

Drug

KAE609 75mg single dose

Primary outcomes

28-day Cure Rate

Time frame: Day 28

28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open Label, Single Dose Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum Malaria Mono-infection

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: May 23, 2013
Registry last updated: Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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