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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05974267




Registration number
NCT05974267
Ethics application status
Date submitted
25/07/2023
Date registered
3/08/2023

Titles & IDs
Public title
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
Scientific 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)
Secondary ID [1] 0 0
MS201618_0034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - M5717 60 mg
Treatment: Drugs - Pyronaridine
Treatment: Drugs - Atovaquone-Proguanil
Treatment: Drugs - M5717 200 mg
Treatment: Drugs - M5717 660mg

Experimental: 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.

Experimental: 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.

Experimental: 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.

Experimental: 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.


Treatment: Drugs: M5717 60 mg
Participants will receive single oral dose (Capsules) of 60 mg M5717 on Day 1 under fasting condition

Treatment: Drugs: 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

Treatment: Drugs: Atovaquone-Proguanil
Participants will Receive Atovaquone-Proguanil tablets 1000/400 mg once daily in a 3-day treatment regimen.

Treatment: Drugs: M5717 200 mg
Participants will receive single oral dose (Capsules) of 200 mg M5717 on Day 1 under fasting condition

Treatment: Drugs: M5717 660mg
Participants will receive single oral dose (Capsules) of 660 mg M5717 on Day 1 under fasting condition
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Parasitemia Since Negative Blood Smear after Treatment
Timepoint [1] 0 0
From Study Start Day 1 up to End of Study (approximately 12 weeks)
Secondary outcome [1] 0 0
Percentage of Participants with Parasitemia (positive blood smear).
Timepoint [1] 0 0
From Study Start Day 1 up to End of Study (approximately 12 week)
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
From Study Start Day 1 up to End of Study (approximately 12 weeks)
Secondary outcome [3] 0 0
Percentage of Participants with PCR-adjusted Parasitemia (Thick Smear/Microscopy, after Adjustment for Parasitemia due to Recrudescence as determined by Genotyping using PCR Techniques)
Timepoint [3] 0 0
From Study Start Day 1 up to End of Study (approximately 12 weeks)
Secondary outcome [4] 0 0
Parasite Clearance Time
Timepoint [4] 0 0
Time from dosing to the first negative (no parasites) blood film (microscopy) , assessed up to 12 weeks
Secondary outcome [5] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
Timepoint [5] 0 0
From Study Start Day 1 up to End of Study (approximately 12 Weeks)
Secondary outcome [6] 0 0
Pharmacokinetic (PK) Plasma Concentrations of M5717 and Pyronaridine
Timepoint [6] 0 0
Predose, 1, 2, 4, 6, 8, and 12 hours on Day 1 and (24 hours) on Day 2

Eligibility
Key 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
Minimum age
12 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Burkina Faso
State/province [1] 0 0
Ouagadougou 06
Country [2] 0 0
Gambia
State/province [2] 0 0
Banjul
Country [3] 0 0
Kenya
State/province [3] 0 0
Kisumu
Country [4] 0 0
Zambia
State/province [4] 0 0
Ndola

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Communication Center
Address 0 0
Country 0 0
Phone 0 0
+49 6151 72 5200
Fax 0 0
Email 0 0
service@emdgroup.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
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
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://bit.ly/IPD21


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05974267