Loading clinical trials...

Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

Phase IIa Proof of Concept, Multicenter, Randomized, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Combination M5717 Plus Pyronaridine Administered Once Daily for 1 or 2 Days to Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

NCT05689047•Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.

Eligibility

Age

12 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with microscopic confirmation of acute uncomplicated Plasmodium falciparum using Giemsa-stained thick and thin film
•P. falciparum parasitemia of 1,000 to 50,000 asexual parasites/microliter of blood in Part A and P. falciparum parasitemia of \>1,000 to \<= 150,000 asexual parasites/microliter of blood in Part B
•Axillary temperature \>= 37.5 degree Celsius or tympanic temperature \>= 38.0 degree Celsius (use as per Coronavirus disease 2019 (COVID-19) protocols at the site \[only at Screening\]), or history of fever during the previous 24 hours (at least documented verbally)
•The Investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable
•Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol

Exclusion Criteria

•Mixed Plasmodium infections as per thin film microscopy results
•Signs and symptoms of severe malaria according to World Health Organisation (WHO) 2021 criteria (WHO 2021)
•Known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis B or C (testing not required), underlying hepatic injury or known severe liver disease, known gallbladder or bile duct disease, acute or chronic pancreatitis, or severe malnutrition
•Known history or evidence of clinically significant disorders such as, cardiovascular, respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological \[including known Human Immunodeficiency Virus-Acquired Immunodeficiency Syndrome (HIV-AIDS)\], neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions, or other abnormality (including head trauma)
•Previous treatment with pyronaridine as part of a combination therapy during the last 3 months
•Prior antimalarial therapy or antibiotics with antimalarial activity within a minimum of their 5 plasma half-lives (or within 4 weeks of Screening if half-life is unknown)
•Participants taking medications prohibited by the protocol

Locations (5)

Institut de Recherche en Sciences de la Santé (IRSS)

Nanoro, Burkina Faso

Groupe de Recherche Action en Santé (GRAS)

Ouagadougou, Burkina Faso

Centre de Recherches Médicales de Lambaréné (CERMEL)

Lambaréné, Gabon

Centro de Investigação em saúde de Manhiça/Fundação Manhiça (CISM/FM)

Maputo, Mozambique

Infectious Diseases Research Collaboration (IDRC)

Tororo, Uganda

Key Dates

Start Date

March 29, 2023

Primary Completion Date

May 28, 2024

Completion Date

May 28, 2024

Last Updated

August 27, 2025

Enrollment

ACTUAL participants

Conditions

Acute Malaria

Interventions

M5717 330 mg

DRUG

M5717 500 mg

DRUG

M5717 660 mg

DRUG

Pyronaridine 360 mg

DRUG

Pyronaridine 360 mg

DRUG

Pyronaridine 540 mg

DRUG

Pyronaridine 720 mg

DRUG