This is Cohort B1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 + Cipargamin in participants with uncomplicated Plasmodium falciparum malaria.
The Cohort B1 of this Platfom study (NCT05750628) is the open-label, randomized, two-arm combination therapy evaluating a dose of up to two anti-malarial agents as a loose combination vs. standard of care (SoC), Coartem in adult and adolescent participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Novartis Investigative Site
Banfora, Burkina Faso
Novartis Investigative Site
Nanoro, Burkina Faso
Novartis Investigative Site
Abidjan, Côte d’Ivoire
Polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR)
ACPR is defined as the absence of parasitemia on Study Day 29 irrespective of axillary temperature, without previously meeting any of the criteria of Early Treatment Failure (ETF) or Late Clinical Failure (LCF) or Late Parasitological Failure (LPF).
Time frame: Day 29
Parasite clearance time (PCT)
To assess the parasite clearance time (PCT) of oral anti malarial agent versus the standard of care (SoC) in participants with uncomplicated P. falciparum malaria
Time frame: up to Day 7
PCR-uncorrected ACPR
To assess the 28-day cure rate of an anti malarial agent administered orally as combination therapy versus the SoC 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 combination therapy.
Time frame: Day 8
Maximum observed concentration (Cmax)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Time to reach maximum observed concentration (Tmax)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Elimination half-life (T1/2)
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Novartis Investigative Site
Azaguié, Côte d’Ivoire
Novartis Investigative Site
Lambaréné, Gabon
Novartis Investigative Site
Libreville, Gabon
Novartis Investigative Site
Kintampo, Ghana
Novartis Investigative Site
Navrongo, Ghana
Novartis Investigative Site
Ahero, Kenya
Novartis Investigative Site
Kisumu, Kenya
...and 3 more locations
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Total body clearance (CL/F)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Apparent volume of distribution (V/F)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Area under the concentration-time curve from time zero to infinity (AUCinf)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8
Area under the concentration-time curve (AUC0-t)
To characterize the pharmacokinetics (PK) of the anti-malarial agent administered orally as combination therapy.
Time frame: Day 8