Uncomplicated Plasmodium falciparum malaria MedDRA version: 20.1 Level: PT Classification code 10035500 Term: Plasmodium falciparum infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 21.1 Level: LLT Classification code 10016171 Term: Falciparum malaria System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: NA
Product Name: KAF156
Product Code: KAF156
Pharmaceutical Form: Tablet
INN or Proposed INN: GANAPLACIDE
CAS Number: 1261113-96-5
Current Sponsor code: KAF156
Concentration unit: mg milli
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •PK Run-in Part and Part A: male and female patients = 12 years and with a body weight = 35.0 kg. •Part B: after determining the effective/tolerated doses and regimens in adolescent and adult patients, male and female patients = 2 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Mixed Plasmodium infections. •Signs and symptoms of severe malaria according to WHO (World Health Organization) 2015 criteria unless characterized by high parasitaemia only. •Patients with concurrent febrile illnesses (e.g., typhoid fever). •Severe vomiting, defined as more than 3 times in the 24 hours prior to inclusion in the study or severe diarrhea defined as more than 3 watery stools per day. •Pregnant or nursing (lactating) women. •Clinically relevant abnormalities of electrolyte balance which require correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia. •Anemia (Hemoglobin level 2 x the upper limit of normal range (ULN), regardless of the level of total bilirubin AST/ALT > 1.5 and = 2 x ULN and total bilirubin is > ULN Total bilirubin > 2 x ULN, regardless of the level of AST/ALT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 29 (i.e., 28 days post-dose): polymerase chain reaction (PCR) corrected adequate clinical and parasitological response (ACPR);Main Objective: To determine the effective doses of KAF156 combined with LUM-SDF given daily over 1, 2 or 3 days for treatment of uncomplicated malaria caused by P. falciparum.;Primary end point(s): •PCR-corrected adequate clinical and parasitological response (ACPR) at Day 29 (i.e., 28 days post-dose) in Parts A and B. •Assessments of KAF156 exposure in the PK Run-in cohort to understand the impact of LUM-SDF on KAF156 exposure. ;Secondary Objective: •To evaluate the safety and tolerability of KAF156/LUM-SDF. •To further assess the effect of treatment with KAF156/LUM-SDF by assessing uncorrected ACPR and corrected ACPR at additional time points, as well as fever- and parasite clearance times. •To assess the key PK parameters of KAF156 and lumefantrine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Days 15, 29 and 43 (i.e., 14, 28 and 42 days post dose): PCR-Uncorrected ACPR Days 15 and 43: PCR-corrected ACPR Proportion of patients with parasitaemia at 12, 24, and 48 hours after treatment. ;Secondary end point(s): •Standard safety/tolerability assessments: AE incidence and severity, liver and kidney function tests and electrocardiogram (ECG) abnormalities. •PCR-Uncorrected ACPR at Days 15, 29and 43 (i.e., 14, 28 and 42 days postdose). PCR-corrected ACPR at Days 15 and 43 (i.e., 14 and 42 days post-dose).Incidence rate of recrudescence and reinfection at Days 15, 29 and 43.Parasite and Fever Clearance Times (PCT and FCT). Proportion of patients with parasitaemia at 12, 24, and 48 hours after treatment. •PK assessments. | — |
Countries
Burkina Faso, Côte d’Ivoire, Gabon, Gambia, India, Kenya, Mali, Mozambique, Thailand, Uganda, Vietnam
Contacts
Public ContactClinical trial Information Desk
Novartis pharma AG
Outcome results
None listed