Phase 2
N=192
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
Malaria Infection
Bottom Line
View on ClinicalTrials.gov: NCT05974267 ↗Enrolled (actual)
192
Serious AEs
0.5%
Results posted
Feb 2026
Primary outcome: Primary: Time to Parasitemia Since Negative Blood Smear After Treatment — 62.0; 60.0; NA; NA days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- M5717 60 mg (Drug); Pyronaridine (Drug); Atovaquone-Proguanil (Drug); M5717 200 mg (Drug); M5717 660mg (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Parasitemia Since Negative Blood Smear After Treatment |
62.0; 60.0; NA; NA | — |
| SECONDARY Percentage of Participants With Parasitemia (Positive Blood Smear) |
53.1; 51.1; 35.4; 37.5 | — |
| SECONDARY Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Parasitemia (Due to New Infections) |
40.8; 36.2; 29.2; 31.3 | — |
| SECONDARY Percentage of Participants With PCR-adjusted Parasitemia (Due to Recrudescence) |
4.1; 12.8; 4.2; 4.2 | — |
| SECONDARY Parasite Clearance Time |
24.1; 24.2; 24.0; 25.0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Treatment Related TEAEs |
31; 27; 31; 28; 0; 1 | — |
| SECONDARY Area Under the Blood Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M5717 and Pyronaridine |
613.64; 2292.02; 9988.92; 5985.14; 6418.17 | — |
| SECONDARY Area Under the Blood Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC 0-24) of M5717 and Pyronaridine |
205.87; 743.74; 3303.65; 1594.05; 1742.89 | — |
| SECONDARY Area Under the Blood Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-tlast) of M5717 and Pyronaridine |
455.40; 2040.41; 9635.73; 5393.62; 5793.71 | — |
| SECONDARY Apparent Total Body Clearance From Blood (CL/f) of M5717 and Pyronaridine |
97.77; 87.25; 66.07; 90.22; 112.18 | — |
| SECONDARY Maximum Observed Blood Concentration (Cmax) of M5717 and Pyronaridine |
15.19; 59.69; 254.50; 157.81; 166.46 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) of M5717 and Pyronaridine |
46.013; 64.663; 90.234; 264.15; 246.94 | — |
| SECONDARY Time to Reach the Maximum Blood Concentration (Tmax) of M5717 and Pyronaridine |
4.067; 4.00; 4.00; 2.10; 2.08 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) During the Terminal Phase of M5717 and Pyronaridine |
6490.76; 8140.36; 8601.43; 34383.091; 39966.70 | — |
Summary
This study evaluates 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.
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 = 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
Data sourced from ClinicalTrials.gov (NCT05974267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.