Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (PLATINUM)

Novartis

Status and phase: Completed; Phase 2

Conditions: Uncomplicated Plasmodium Falciparum Malaria

Treatments: Drug: INE963

Study type: Interventional

Funder types: Industry

Identifiers

NCT07235020

CADPT13A12201_A1

Details and patient eligibility

About

This is Cohort A1 of the Platform study (NCT05750628) to evaluate the efficacy and safety of INE963 in participants with uncomplicated Plasmodium falciparum malaria.

Full description

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).

Enrollment: 52 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female patients ≥18 years of age 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
3. Patients must weigh between 40 kg and 90 kg.
4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.

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) < 50 bpm

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 4 patient groups

Cohort A1: INE963 Dose Level 1

Experimental group

Description:

Cohort A1: INE963 Dose Level 1

Treatment:

Drug: INE963

Cohort A1: INE963 Dose Level 2

Experimental group

Description:

Cohort A1: INE963 Dose Level 2

Treatment:

Drug: INE963

Cohort A1: INE963 Dose Level 3

Experimental group

Description:

Cohort A1: INE963 Dose Level 3

Treatment:

Drug: INE963

Cohort A1: INE963 Dose Level 4

Experimental group

Description:

Cohort A1: INE963 Dose Level 4

Treatment:

Drug: INE963