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A Multi-part, Multi-center Platform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-malarial Agents Administered Alone or Combined in Patients With Uncomplicated Plasmodium Falciparum Malaria
Led by Novartis Pharmaceuticals · Updated on 2025-07-30
327
Participants Needed
12
Research Sites
2 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating how well different anti-malarial drugs work and how safe they are for treating uncomplicated Plasmodium falciparum malaria in adults, adolescents, and children. This study focuses on the parasite-killing effects and potential cure rates of these drugs when given alone or combined with others. It also looks at how the drugs are processed by the body to help decide doses for future studies. Participants will receive one of several treatments, including varying doses of the oral drug INE963, combinations of oral KAE609 (Cipargamin) with INE963 or KLU156, or the standard of care drug Coartem. The study has multiple parts with patients allocated randomly to different treatment groups. Dosing levels and combinations are tested to compare how effectively they clear the malaria parasite. During the study, participants will have their parasite levels monitored up to 7 days and clinical response assessed by day 29. Blood samples will be taken by day 22 to study drug levels and how the body absorbs and clears the medicines. Safety is monitored through reports of side effects until day 43. The total participation lasts through these assessments to understand treatment impact and tolerability.
CONDITIONS
Brief Title
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 18 years or older for Part A, 12 years or older for Part B, and 2 to less than 12 years for Part C at screening
- Acute uncomplicated Plasmodium falciparum malaria mono infection confirmed by parasite count: 5,000 to 150,000 parasites/µl for Part A, 1,000 to 150,000 parasites/µl for Parts B and C
- Weight between 40 and 90 kg for Part A, between 35 and 90 kg for Part B, and at least 10 kg for Part C at screening
- Body temperature of 37.5ºC or higher (axillary) or 38.0ºC or higher (oral/tympanic/rectal), or history of fever in the past 24 hours
You will not qualify if you...
- Signs or symptoms of severe or complicated malaria or mixed Plasmodium infection at screening
- Moderate to severe anemia, chronic hemoglobinopathy, or known chronic disease such as sickle cell disease
- Clinically significant liver disease or abnormal liver function tests exceeding specified limits
- Known or suspected immunosuppressive or immunodeficient conditions, including HIV infection
- Pregnancy or nursing women, or women of child-bearing potential not using effective contraception
- History or current diagnosis of significant cardiac problems, including certain arrhythmias, long QT syndrome, or resting heart rate below 50 bpm
- Other protocol-defined criteria may also apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive anti-malarial agents either as monotherapy or combination therapy to treat uncomplicated Plasmodium falciparum malaria.
Daily visits during treatment period
Duration - Up to 36 days after treatment
Participants are monitored for safety, tolerability, and parasitological response after completing treatment.
Visits at Days 22, 29, and 43
Trial Site Locations
Total: 12 locations
1
Novartis Investigative Site
Banfora, Burkina Faso
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2
Novartis Investigative Site
Nanoro, Burkina Faso, BP 18
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3
Novartis Investigative Site
Abidjan, Côte d’Ivoire, 13BP972
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4
Novartis Investigative Site
Azaguié, Côte d’Ivoire, BP 173
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5
Novartis Investigative Site
Lambaréné, Gabon, BP 242
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6
Novartis Investigative Site
Libreville, Gabon, BP 1437
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7
Novartis Investigative Site
Kintampo, Ghana, 92037
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8
Novartis Investigative Site
Navrango, Ghana, VWJ6+8WF
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9
Novartis Investigative Site
Ahero, Kisumu County, Kenya, 40100
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10
Novartis Investigative Site
Kisumu, Kenya, 40100
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11
Novartis Investigative Site
Kampala, Uganda
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12
Novartis Investigative Site
Tororo, Uganda, 10102
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Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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