A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers

Launched by ZYDUS LIFESCIENCES LIMITED · Jun 18, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new combination of two medications, ZY19489 and ferroquine, to see how safe they are and how well they work when taken by mouth for treating asymptomatic malaria caused by the Plasmodium falciparum parasite. The aim is to find a treatment that can be taken in just one or two days, making it easier for patients to stick to their medication and potentially reducing the spread of malaria. The study is currently looking for adult men and women aged 18 to 55 who have been found to carry the malaria parasite but do not show any symptoms.

Participants in the trial can expect to take the medication for a short period and will be closely monitored for any side effects or reactions. To be eligible, individuals must weigh at least 45 kg and should not have any other significant health issues or recent infections. It's also important that participants do not have any mixed infections or have taken certain malaria medications recently. This study is a crucial step in finding effective treatments for malaria, especially for those who may not show symptoms but still carry the disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - 1. Male and female (non-pregnant, non-lactating) subjects aged between 18 and 55 years old 2. Participant's body weight ≥ 45 kg 3. Evidence of asymptomatic infection with Plasmodium falciparum mono-infection on microscopy with parasite density between 20/µL and 5000/µL.
• • 4. Participants should agree to not donate blood from enrolment in the study until end of the follow-up period 5. Ability to swallow oral medication 6. Evidence of written informed consent personally signed and dated by the participant.
• • Signed informed consent obtained prior to participation in the study. In case of participant unable to read and write or otherwise incapable of signing an informed consent, an impartial witnessed consent shall be obtained. Participants who are willing to and are able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Exclusion Criteria:
• • 1. Mixed Plasmodium infection as judged by microscopy. 2. Presence of clinically significant infectious disease or fever (e.g. Body temperature ≥38°C or 100.4°F) within the 14 days prior to enrollment.
• • 3. History of alcohol or drug abuse or positive urine alcohol test or urine drug test.
• • 4. Consumption of beverages or food containing xanthine bases including chocolate, coffee etc. from 48 hours prior to enrollment.
• • 5. Known allergy to the study drugs and to the rescue medications (artemisinin derivatives, lumefantrine) as well as their excipients.
• 6. History of having received any antimalarial treatment (alone or in combination) during the following periods before screening:
• • 1. Piperaquine, mefloquine, naphthoquine or sulfadoxine-pyrimethamine within 6 weeks prior to screening.
• • 2. Amodiaquine, chloroquine within 4 weeks prior to screening.
• • 3. Any artemisinin derivative (artesunate, artemether or dihydroartemisinin), quinine, lumefantrine or any other anti-malarial treatment or antibiotic with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones and azithromycin) within 14 days prior to screening.
• • 7. Laboratory parameters outside normal range or with clinically relevant abnormalities as per investigator's judgment.
• • 8. Electrolyte levels outside normal range 9. Hematology, clinical chemistry or urinalysis results at screening that were outside of clinically acceptable laboratory ranges and were considered clinically significant by the Investigator.
• • 10. GFR\<60 ml/min. 11. Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance within 3 months of screening.
• • 12. Participation in other clinical studies within 90 days before screening. 13. Pregnant or nursing (lactating) women. 14. Sexually active participants not willing to take effective contraception measures from enrolment until the last study visit: For female participants, combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner.
• • 15. All male participants not willing to use either true abstinence, barrier method or with their sexual partner, the use of effective means of contraception from enrolment and until the last study visit.
• • 16. Participant who the investigator considers at particular risk of receiving an anti-malarial or of participating in the study.