Last Update: May 22, 2024
A Multi-part, Multi-center PLATform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-malarial Agents Administered as Monotherapy and/or Combination Therapy IN Patients With Uncomplicated Plasmodium Falciparum Malaria
ClinicalTrials.gov Identifier:
Novartis Reference Number:CADPT13A12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

Platform study to evaluate the efficacy and safety of anti-malarial agents in patients
with uncomplicated Plasmodium falciparum malaria The purpose of this platform study is to evaluate the parasiticidal effect and potential
for cure with different anti-malarial agents administered as monotherapy and/or in
combination therapy with other anti-malarial agents in adult and adolescent patients with
uncomplicated Plasmodium falciparum malaria. Additionally, the safety, tolerability, and
pharmacokinetics of these anti-malarial agents will be evaluated for dose selection for
future studies.

Uncomplicated Plasmodium Falciparum Malaria
Phase2
Recruiting
327
Jan 23, 2024
May 04, 2026
All
12 Years - (Child, Adult, Older Adult)

Interventions

Drug

INE963

oral INE963
Drug

KAE609 (Cipargamin)

oral KAE609 (Cipargamin)
Drug

KLU156

oral sachet KLU156 (KAF156 + lumefantrine)
Drug

SoC (Coartem)

SoC (Coartem)

Eligibility Criteria

Inclusion Criteria:

1. Male and female patients ≥18 years of age for Part A and ≥12 years of age for Part B
at screening.

2. Patients must have acute uncomplicated P. falciparum malaria mono infection at
screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite
count/μl of blood for P. falciparum for Part A and between 1,000 to 150,000 asexual
parasite count/μl of blood for Part B

3. Patients in Part A must weigh between 40 kg and 90 kg. Patients in Part B must weigh
between 35 kg and 90 kg at screening.

Exclusion Criteria:

1. Patients with signs and symptoms of severe/complicated malaria at screening or mixed
Plasmodium infection (i.e., infection with more than one malaria species) at
screening

2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level < 8 g/dL), or
known chronic underlying disease such as sickle cell disease at screening

3. Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis
(compensated or decompensated), history of hepatitis B or C, hepatitis A or B
vaccination in the last 3 months, known gallbladder or bile duct disease, acute or
chronic pancreatitis. Clinical or laboratory evidence of any of the following at
screening:

- AST/ALT > 3 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

4. Any known/suspected immunosuppressive or immunodeficient condition, including human
immunodeficiency virus (HIV) infection at screening.

5. Pregnant or nursing (lactating) women, women of child-bearing potential, defined as
all women physiologically capable of becoming pregnant, unless they are using
methods of effective contraception, and sexually active patients not willing to
practice effective contraception.

6. History or current diagnosis of ECG abnormalities indicating significant risk of
safety for patients participating in the study such as:

- Concomitant clinically significant cardiac arrhythmias, e.g., sustained
ventricular tachycardia, and clinically significant second or third degree AV
block without a pacemaker

- History of familial long QT syndrome or known family history of Torsades de
Pointe.

- Resting heart rate (physical exam or 12 lead ECG) < 60 bpm

Other protocol-defined inclusion/exclusion criteria may apply.

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