This is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria.
The Cohort A1 of this Platfom study (NCT05750628) is an open-label, randomized, multi-arm monotherapy part evaluating a single oral administration of an anti-malarial agent (INE963) at 3 parallel dose levels followed by optional adaptive sequential dose level(s).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Administered via oral INE963
Novartis Investigative Site
Banfora, Burkina Faso
Novartis Investigative Site
Azaguié, Côte d’Ivoire
Novartis Investigative Site
Lambaréné, Gabon
Novartis Investigative Site
Navrongo, Ghana
Parasite clearance time (PCT)
To assess the parasite clearance time (PCT) of oral doses of an anti-malarial agent administered as monotherapy in participants with uncomplicated P. falciparum malaria. PCT is defined as the time from the first positive blood slide at inclusion to the time of the first negative slide followed by two consecutive slides.
Time frame: up to Day 7
PCR-corrected and uncorrected ACPR
To assess the 28-day cure rate of an anti malarial agent administered orally as monotherapy in participants with uncomplicated P. falciparum malaria.
Time frame: Day 29
Area under the concentration-time curve from time zero to the last measurable concentration sampling time (AUClast)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Area under the concentration-time curve from time zero to infinity (AUCinf)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Maximum observed concentration (Cmax)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Time to reach maximum observed concentration (Tmax)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Elimination half-life (T1/2)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
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Novartis Investigative Site
Kisumu, Kenya
Novartis Investigative Site
Kampala, Uganda
Time frame: Day 22
Total body clearance (CL/F)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Apparent volume of distribution (V/F)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22
Area under the concentration-time curve (AUC0-t)
To characterize PK of the anti-malarial agent administered orally as monotherapy.
Time frame: Day 22