Back to resultsEfficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
Primary Purpose
Malaria Infection
Status
Not yet recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
M5717 60 mg
Pyronaridine
Atovaquone-Proguanil
M5717 200 mg
M5717 660mg
Sponsored by
About this trial
This is an interventional treatment trial for Malaria Infection focused on measuring Plasmodium falciparum, Chemoprevention, Malaria, Plasmodium eukaryotic translation elongation factor 2 (PeEF2), Exposure response, Adults, Adolescents, Asymptomatic Infection
Eligibility Criteria
Inclusion Criteria: 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. 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 Other Protocol defined Inclusion Criteria could apply Exclusion Criteria: Participants with any disease requiring Chronic Treatment 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 Other protocol defined Exclusion Criteria could apply
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1: M5717 (60 mg) + Pyronaridine
Cohort 2: M5717 (200 mg) + Pyronaridine
Cohort 3: M5717 (660 mg)+ Pyronaridine
Cohort 4: Atovaquone-proguanil
Arm 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.
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.
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.
Participants will receive orally 3 doses of Malarone (fixed-dose combination of atovaquone-proguanil) once daily in a 3-day treatment regimen.
Outcomes
Primary Outcome Measures
Time to Parasitemia Since Negative Blood Smear after Treatment
Secondary Outcome Measures
Percentage of Participants with Parasitemia (positive blood smear).
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)
Percentage of Participants with PCR-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to Recrudescence as determined by Genotyping using PCR Techniques)
Parasite Clearance Time
Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
Pharmacokinetic (PK) Plasma Concentrations of M5717 and Pyronaridine
Full Information
NCT ID
NCT05974267
First Posted
July 25, 2023
Last Updated
August 2, 2023
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
1. Study Identification
Unique Protocol Identification Number
NCT05974267
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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 25, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria Infection
Keywords
Plasmodium falciparum, Chemoprevention, Malaria, Plasmodium eukaryotic translation elongation factor 2 (PeEF2), Exposure response, Adults, Adolescents, Asymptomatic Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Open Label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: M5717 (60 mg) + Pyronaridine
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 2: M5717 (200 mg) + Pyronaridine
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 3: M5717 (660 mg)+ Pyronaridine
Arm Type
Experimental
Arm 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.
Arm Title
Cohort 4: Atovaquone-proguanil
Arm Type
Experimental
Arm Description
Participants will receive orally 3 doses of Malarone (fixed-dose combination of atovaquone-proguanil) once daily in a 3-day treatment regimen.
Intervention Type
Drug
Intervention Name(s)
M5717 60 mg
Intervention Description
Participants will receive single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition
Intervention Type
Drug
Intervention Name(s)
Pyronaridine
Other Intervention Name(s)
Pyronaridine tetraphosphate
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Atovaquone-Proguanil
Intervention Description
Participants will Receive Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen.
Intervention Type
Drug
Intervention Name(s)
M5717 200 mg
Intervention Description
Participants will receive single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition
Intervention Type
Drug
Intervention Name(s)
M5717 660mg
Intervention Description
Participants will receive single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition
Primary Outcome Measure Information:
Title
Time to Parasitemia Since Negative Blood Smear after Treatment
Time Frame
From Study Start Day 1 up to End of Study (approximately 12 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Participants with Parasitemia (positive blood smear).
Time Frame
From Study Start Day 1 up to End of Study (approximately 12 week)
Title
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)
Time Frame
From Study Start Day 1 up to End of Study (approximately 12 weeks)
Title
Percentage of Participants with PCR-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to Recrudescence as determined by Genotyping using PCR Techniques)
Time Frame
From Study Start Day 1 up to End of Study (approximately 12 weeks)
Title
Parasite Clearance Time
Time Frame
Time from dosing to the first negative (no parasites) blood film (microscopy) , assessed up to 12 weeks
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
Time Frame
From Study Start Day 1 up to End of Study (approximately 12 Weeks)
Title
Pharmacokinetic (PK) Plasma Concentrations of M5717 and Pyronaridine
Time Frame
Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and (24 hours) on Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Other Protocol defined Inclusion Criteria could apply
Exclusion Criteria:
Participants with any disease requiring Chronic Treatment
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
Other protocol defined Exclusion Criteria could apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Communication Center
Phone
+49 6151 72 5200
Email
service@emdgroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Darmstadt
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Please Contact the Communication Center
Phone
+49 6151 72 5200
Email
service@emdgroup.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan 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
IPD Sharing Time Frame
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
IPD Sharing Access Criteria
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.
IPD Sharing URL
http://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en
Description
Trial Awareness and Transparency website
Learn more about this trial
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
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