Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 1:30 AM
Study NCT ID:
NCT05974267
Status:
COMPLETED
Last Update Posted:
2025-10-08
First Post:
2023-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016778', 'term': 'Malaria, Falciparum'}, {'id': 'D008288', 'term': 'Malaria'}, {'id': 'D058345', 'term': 'Asymptomatic Infections'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D058070', 'term': 'Asymptomatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C027871', 'term': 'pyronaridine'}, {'id': 'C109496', 'term': 'atovaquone, proguanil drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open Label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-07', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Parasitemia Since Negative Blood Smear after Treatment', 'timeFrame': 'From Study Start Day 1 up to End of Study (approximately 12 weeks)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with Parasitemia (positive blood smear).', 'timeFrame': 'From Study Start Day 1 up to End of Study (approximately 12 week)'}, {'measure': 'Percentage of Participants with Polymerase Chain Reaction (PCR)-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to new Infections as determined by Genotyping using PCR Techniques)', 'timeFrame': 'From Study Start Day 1 up to End of Study (approximately 12 weeks)'}, {'measure': 'Percentage of Participants with PCR-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to Recrudescence as determined by Genotyping using PCR Techniques)', 'timeFrame': 'From Study Start Day 1 up to End of Study (approximately 12 weeks)'}, {'measure': 'Parasite Clearance Time', 'timeFrame': 'Time from dosing to the first negative (no parasites) blood film (microscopy) , assessed up to 12 weeks'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs', 'timeFrame': 'From Study Start Day 1 up to End of Study (approximately 12 Weeks)'}, {'measure': 'Pharmacokinetic (PK) Plasma Concentrations of M5717 and Pyronaridine', 'timeFrame': 'Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and (24 hours) on Day 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plasmodium falciparum', 'Chemoprevention', 'Malaria', 'Plasmodium eukaryotic translation elongation factor 2 (PeEF2)', 'Exposure response', 'Adults', 'Adolescents', 'Asymptomatic Infection'], 'conditions': ['Malaria Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/?id=ms201618_0034', 'label': 'Trial Awareness and Transparency website'}, {'url': 'https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html', 'label': 'Medical Information Location Map - Med Info Contacts'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and adolescents. The study will also assess the duration of protection provided by different doses of M5717 plus pyronaridine and the additional contribution of M5717 to the duration of protection using external study data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with Asymptomatic Plasmodium falciparum Malaria with no Fever or other sign of Acute Uncomplicated Malaria and, with Microscopic confirmation using Giemsa-stained thick film, and a Parasitemia of \\>= 40 to \\<= 10,000 Asexual Parasites/Microliter (μL) of Blood.\n* Axillary Temperature \\< 37.0 degree Celcius (ºC) or oral/Tympanic/rectal Temperature\\< 37.5ºC; without history of fever during the previous 48 hours.\n* Have a body weight \\>= 45 kilogram (kg)\n* Participants capable of giving Signed Informed consent which includes Compliance with the requirements and restriction listed in the Informed consent form\n* Other Protocol defined Inclusion Criteria could apply\n\nExclusion Criteria:\n\n* Participants with any disease requiring Chronic Treatment\n* Participants with any Preplanned surgery during the study\n* Participants with any previous Treatment with pyronaridine as part of a combination therapy during the last 3 months\n* Participants with any adequate Hematological, Hepatic, and renal function as defined in the Protocol\n* Other protocol defined Exclusion Criteria could apply'}, 'identificationModule': {'nctId': 'NCT05974267', 'briefTitle': 'Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Phase 2a Proof-of-Concept, Multicenter, Randomized, Open Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of the Combination M5717-pyronaridine as Chemoprevention in Asymptomatic Adults and Adolescents With Plasmodium Falciparum Malaria Infection (CAPTURE-2)', 'orgStudyIdInfo': {'id': 'MS201618_0034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: M5717 (60 mg) + Pyronaridine', 'description': '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.', 'interventionNames': ['Drug: M5717 60 mg', 'Drug: Pyronaridine']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: M5717 (200 mg) + Pyronaridine', 'description': '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.', 'interventionNames': ['Drug: Pyronaridine', 'Drug: M5717 200 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: M5717 (660 mg)+ Pyronaridine', 'description': '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.', 'interventionNames': ['Drug: Pyronaridine', 'Drug: M5717 660mg']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: Atovaquone-proguanil', 'description': 'Participants will receive orally 3 doses of Malarone (fixed-dose combination of atovaquone-proguanil) once daily in a 3-day treatment regimen.', 'interventionNames': ['Drug: Atovaquone-Proguanil']}], 'interventions': [{'name': 'M5717 60 mg', 'type': 'DRUG', 'description': 'Participants will receive single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition', 'armGroupLabels': ['Cohort 1: M5717 (60 mg) + Pyronaridine']}, {'name': 'Pyronaridine', 'type': 'DRUG', 'otherNames': ['Pyronaridine tetraphosphate'], 'description': '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', 'armGroupLabels': ['Cohort 1: M5717 (60 mg) + Pyronaridine', 'Cohort 2: M5717 (200 mg) + Pyronaridine', 'Cohort 3: M5717 (660 mg)+ Pyronaridine']}, {'name': 'Atovaquone-Proguanil', 'type': 'DRUG', 'description': 'Participants will Receive Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen.', 'armGroupLabels': ['Cohort 4: Atovaquone-proguanil']}, {'name': 'M5717 200 mg', 'type': 'DRUG', 'description': 'Participants will receive single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition', 'armGroupLabels': ['Cohort 2: M5717 (200 mg) + Pyronaridine']}, {'name': 'M5717 660mg', 'type': 'DRUG', 'description': 'Participants will receive single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition', 'armGroupLabels': ['Cohort 3: M5717 (660 mg)+ Pyronaridine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ouagadougou', 'country': 'Burkina Faso', 'facility': 'Groupe de Recherche Action en Sante (GRAS)', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}, {'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Kisumu County Referral Hospital', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Banjul', 'country': 'The Gambia', 'facility': 'MRC Unit The Gambia at LSHTM', 'geoPoint': {'lat': 13.45274, 'lon': -16.57803}}, {'city': 'Ndola', 'country': 'Zambia', 'facility': 'Ndola Teaching Hospital', 'geoPoint': {'lat': -12.95867, 'lon': 28.63659}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'ipdSharingStatementModule': {'url': 'http://bit.ly/IPD21', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union', 'ipdSharing': 'YES', 'description': 'We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21', 'accessCriteria': "Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}