Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
NCT ID: NCT05974267
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
192 participants
INTERVENTIONAL
2023-11-28
2024-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: M5717 (60 mg) + Pyronaridine
Participants will receive single oral dose of M5717 60 milligram (mg) plus pyronaridine tetraphosphate (pyronaridine) 720 mg (Participants \>= 65 kilogram \[kg\]) or pyronaridine 540 mg (Participants \>= 45 to \< 65 kg) once daily in a single day treatment regimen.
M5717 60 mg
Participants will receive single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition
Pyronaridine
Participants will receive Pyronaridine tablets orally single dose of 720 (Participants \>= 65 kg) and 540 mg (Participants \>= 45 to \< 65 kg) on Study Day 1 under fasting condition
Cohort 2: M5717 (200 mg) + Pyronaridine
Participants will receive single oral dose of M5717 200 mg plus pyronaridine 720 mg (Participants \>= 65 kg) or pyronaridine 540 mg (Participants \>= 45 to \< 65 kg) once daily in a single day treatment regimen.
Pyronaridine
Participants will receive Pyronaridine tablets orally single dose of 720 (Participants \>= 65 kg) and 540 mg (Participants \>= 45 to \< 65 kg) on Study Day 1 under fasting condition
M5717 200 mg
Participants will receive single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition
Cohort 3: M5717 (660 mg)+ Pyronaridine
Participants will receive single oral dose of M5717 660 mg plus pyronaridine 720 mg (Participants \>= 65 kg) or pyronaridine 540 mg (Participants \>= 45 to \< 65 kg) once daily in a single day treatment regimen.
Pyronaridine
Participants will receive Pyronaridine tablets orally single dose of 720 (Participants \>= 65 kg) and 540 mg (Participants \>= 45 to \< 65 kg) on Study Day 1 under fasting condition
M5717 660mg
Participants will receive single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition
Cohort 4: Atovaquone-proguanil
Participants will receive orally 3 doses of Malarone (fixed-dose combination of atovaquone-proguanil) once daily in a 3-day treatment regimen.
Atovaquone-Proguanil
Participants will Receive Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen.
Interventions
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M5717 60 mg
Participants will receive single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition
Pyronaridine
Participants will receive Pyronaridine tablets orally single dose of 720 (Participants \>= 65 kg) and 540 mg (Participants \>= 45 to \< 65 kg) on Study Day 1 under fasting condition
Atovaquone-Proguanil
Participants will Receive Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen.
M5717 200 mg
Participants will receive single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition
M5717 660mg
Participants will receive single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Axillary Temperature \< 37.0 degree Celcius (ºC) or oral/Tympanic/rectal Temperature\< 37.5ºC; without history of fever during the previous 48 hours.
* Have a body weight \>= 45 kilogram (kg)
* Participants capable of giving Signed Informed consent which includes Compliance with the requirements and restriction listed in the Informed consent form
Exclusion Criteria
* Participants with any Preplanned surgery during the study
* Participants with any previous Treatment with pyronaridine as part of a combination therapy during the last 3 months
* Participants with any adequate Hematological, Hepatic, and renal function as defined in the Protocol
12 Years
55 Years
ALL
No
Sponsors
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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Groupe de Recherche Action en Sante (GRAS)
Ouagadougou, , Burkina Faso
Kisumu County Referral Hospital
Kisumu, , Kenya
MRC Unit The Gambia at LSHTM
Banjul, , The Gambia
Ndola Teaching Hospital
Ndola, , Zambia
Countries
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Related Links
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Trial Awareness and Transparency website
Medical Information Location Map - Med Info Contacts
Other Identifiers
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MS201618_0034
Identifier Type: -
Identifier Source: org_study_id
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