Efficacy, Safety, Tolerability, and Pharmacokinetics of ZY-19489 in Indian patients with Uncomplicated Plasmodium Falciparum Malaria

Phase 2

Completed

• Conditions: Health Condition 1: B509- Plasmodium falciparum malaria, unspecified

• Registration Number: CTRI/2022/11/047394
• Lead Sponsor: Zydus Lifesciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-11-13
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 145

Inclusion Criteria

1. Ability to swallow oral medication

2. Participants who are willing to and are able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

3. Participants able to understand and willing to give the informed consent for their participation in the study..

4. Microscopic confirmation of Plasmodium falciparum monoinfection by thin and thick blood smears counts of more than 1000 and less than 100,000 parasites/uL

5. Axillary temperature = 37.5°C or oral/tympanic/rectal temperature = 38 °C

6. Participants with age 18 to 55 years (both inclusive) and body weight >45 kg

7. Hb >9 g/dl

Exclusion Criteria

1. Mixed Plasmodium infection

2. Signs and symptoms of severe malaria

3. Clinically relevant abnormalities of electrolytes, eg hypokalemia, hypocalcemia or hypomagnesemia.

4. Severe vomiting, defined as more than 3 times in the 24 hours prior to inclusion in the study or severe diarrhea defined as more than 3 watery stools per day.

5. History of having received any antimalarial treatment (alone or in combination) during the following periods before screening:

• Piperaquine, mefloquine, naphthoquine or sulfadoxine-pyrimethamine within 6 weeks prior to screening

• Amodiaquine, chloroquine within 4 weeks prior to screening

• 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

6. Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance within 3 months of screening.

7. Any herbal products or traditional medicines during the 7 days prior to screening (if spontaneously reported by the patient)

8. Known allergy to the study drugs (pyronaridine derivatives/Artemisinin derivatives/Lumefantrine) and its excipients.

9. Pregnant or nursing (lactating) women.

10. Sexually active participants not willing to take effective contraception measures: For female participants oral contraceptive pills, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner. Female participants on oral contraceptive do not agree to use double method of contraception. For male subjects, who do not agree to use double barrier method or with their sexual partner the use of effective means of contraception.

11. Participation in other clinical studies within 90 days before screening

12. Inability to comprehend and/or unwillingness to follow the study protocol

13. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Examples would include but not limited to:

Known Tuberculosis

• Concurrent febrile illness, eg typhoid fever or known or suspected COVID 19 infection

• Immunological disorders (including known or suspected seropositive HIV antibody),

• Severe psychiatric disorders (active depression, recent history of depression, generalised anxiety, psychosis, schizophrenia or other major psychiatric disorders) and major medical disorders related to cardiovascular, respiratory (including active tuberculosis), renal, gastrointestinal, endocrine, infectious, malignancy, neurological (including auditory) and history of convulsions or other abnormality (including recent head trauma),

• Clinical signs or symptoms of hepatic injury (such as nausea, abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, Child-Pugh stage 3 or 4), history of hepatitis B or C, hepatitis B or A vaccination in the last 3 months, known gallbladder or bile duct disease, acute or ch

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of ZY-19489 with Coartem® in the treatment of symptomatic adults with uncomplicated plasmodium falciparum malaria mono infection as measured by PCR-adjusted ACPR on Day 29Timepoint: PCR-adjusted ACPR at Day 29