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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2024-05-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)

NCT05974267

Malaria Infection

COMPLETED PHASE2

Phase2a Primaquine Dose Escalation Study

NCT01743820

Malaria

COMPLETED PHASE2

Controlled Human Malaria Infection Model for Evaluation of Transmission-blocking Interventions - Study 2

NCT03454048

Malaria,Falciparum Gametocytes Controlled Human Malaria Infection +1 more

COMPLETED NA

Controlled Human Malaria Infection Model for Evaluation of Transmission-Blocking Interventions - Study 1

NCT02836002

Malaria

COMPLETED PHASE1/PHASE2

A Study to Evaluate the Pharmacokinetics of Oral Formulations of MMV390048 Administered Fasted to Healthy Volunteers

NCT02554799

Malaria

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A: Safety Run-in Cohort M5717+Pyronaridine

M5717 and pyronaridine once daily in a single day treatment regimen at low dose of 330 milligrams (mg) and 360 mg respectively.

Group Type EXPERIMENTAL

M5717 330 mg

Intervention Type DRUG

Participants will receive orally 330 mg granules of M5717 in combination with pyronaridine dispersed in water under fasting condition.

Pyronaridine 360 mg

Intervention Type DRUG

Participants will receive 360 mg of pyronaridine tablets in combination with M5717 under fasting condition.

Part B: Dose escalation cohort; M5717+Pyronaridine

After completion of Part A, if dose will be considered safe and well tolerated, the Internal Data Monitoring Committee (IDMC) will have the option to recommend dose adjustments. M5717 and pyronaridine once daily will be administered in an escalated dose in a single day or 2-day treatment regimen.

Group Type EXPERIMENTAL

M5717 500 mg

Intervention Type DRUG

Adolescent participants with weight less than (\<) 45 kilograms (kg) will receive orally 500 mg granules of M5717 in combination with pyronaridine dispersed in water once daily under fasting condition.

M5717 660 mg

Intervention Type DRUG

Adult and adolescent participants with weight more than or equal to (\>=) 45 kg will receive orally 660 mg granules of M5717 in combination with pyronaridine dispersed in water once daily under fasting condition.

Pyronaridine 360 mg

Intervention Type DRUG

Participants with weight \>=24 to \<45 kg will receive 360 mg of tablets in combination with M5717 under fasting condition.

Pyronaridine 540 mg

Intervention Type DRUG

Participants with weight \>=45 to \<65 kg will receive 540 mg of Pyronaridine tablets in combination with M5717 under fasting condition.

Pyronaridine 720 mg

Intervention Type DRUG

Participants with weight \>=65 kg will receive 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

M5717 330 mg

Participants will receive orally 330 mg granules of M5717 in combination with pyronaridine dispersed in water under fasting condition.

Intervention Type DRUG

M5717 500 mg

Adolescent participants with weight less than (\<) 45 kilograms (kg) will receive orally 500 mg granules of M5717 in combination with pyronaridine dispersed in water once daily under fasting condition.

Intervention Type DRUG

M5717 660 mg

Adult and adolescent participants with weight more than or equal to (\>=) 45 kg will receive orally 660 mg granules of M5717 in combination with pyronaridine dispersed in water once daily under fasting condition.

Intervention Type DRUG

Pyronaridine 360 mg

Participants will receive 360 mg of pyronaridine tablets in combination with M5717 under fasting condition.

Intervention Type DRUG

Pyronaridine 360 mg

Participants with weight \>=24 to \<45 kg will receive 360 mg of tablets in combination with M5717 under fasting condition.

Intervention Type DRUG

Pyronaridine 540 mg

Participants with weight \>=45 to \<65 kg will receive 540 mg of Pyronaridine tablets in combination with M5717 under fasting condition.

Intervention Type DRUG

Pyronaridine 720 mg

Participants with weight \>=65 kg will receive 720 mg of Pyronaridine tablets in combination with M5717 under fasting condition.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No