Actively Recruiting
A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers
Led by Zydus Lifesciences Limited · Updated on 2024-10-01
36
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Malaria is caused by protozoan parasites of the genus Plasmodium and it is the most important parasitic disease in terms of mortality and morbidity. Estimates of 247 million malaria cases and 619.000 deaths worldwide were reported by WHO for the year 2021 (1). Plasmodium falciparum can lead to severe malaria and accounts for 90% of malaria deaths that mainly occur in children below the age of 5 years in Sub-Saharan Africa. A simplified treatment regimen, ideally a single-day cure (or at most 2-day dosing regimen), of uncomplicated malaria due to P. falciparum would be the magic in the antimalarial armamentarium. Improving treatment adherence is one of the key factors in reducing mortality and morbidity and also the transmission of malaria, and such a regimen would substantially increase adherence. To find a new non-artemisinin combination therapy with a shorter regimen, ideally, a single-dose cure, with low resistance potential would be the aim. The two compounds tested here are ZY19489, a triaminopyrimidine, and ferroquine (FQ), a next-generation 4-aminoquinoline. Both compounds show unique features in terms of long half-life, and activity against current drug-resistant strains. Therefore, the main goal of this clinical trial is to assess the safety of the ZY19489-FQ combination given as a 1- or 2-day dose regimen.
CONDITIONS
Official Title
A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female (non-pregnant, non-lactating) aged 18 to 55 years
- Body weight of at least 45 kg
- Evidence of asymptomatic Plasmodium falciparum mono-infection with parasite density between 20/µL and 5000/µL
- Agreement not to donate blood during study participation
- Ability to swallow oral medication
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Mixed Plasmodium infection
- Clinically significant infectious disease or fever (≥38°C or 100.4°F) within 14 days before enrollment
- History of alcohol or drug abuse or positive tests for alcohol or drugs
- Consumption of xanthine-containing foods or drinks within 48 hours before enrollment
- Known allergy to study drugs or rescue medications including artemisinin derivatives and lumefantrine
- Use of specific antimalarial treatments within defined periods before screening (e.g., piperaquine, mefloquine within 6 weeks; chloroquine within 4 weeks; artemisinin derivatives or antibiotics with antimalarial activity within 14 days)
- Laboratory or clinical abnormalities considered clinically significant by the investigator
- Glomerular filtration rate below 60 ml/min
- Participation in malaria vaccine studies or receipt of malaria vaccine within 3 months before screening
- Participation in other clinical studies within 90 days before screening
- Pregnant or nursing women
- Participants unwilling to use effective contraception during the study
- Investigator judgment of particular risk for receiving antimalarial treatment or study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre de Recherches Médicales de Lambaréné
Lambaréné, Gabon
Actively Recruiting
Research Team
K
Kevinkumar Kansagra, MD
CONTACT
D
Dr Hardik Patel, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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