Healthy Clinical Trial
Official title:
Open-Label Study to Evaluate Pharmacokinetic Properties and Mosquito-Lethal Effect of Ivermectin Metabolites in Healthy Adult Subjects
This clinical trial will be designed to capture the full duration of mosquito-lethal effect of single dose Ivermectin to aid efforts to characterize metabolites with mosquito-lethal effect. Ivermectin and its metabolites likely have antiparasitic properties against asexual and sexual stage Plasmodium parasites that will be investigated with plasma samples from this study. This is an open-label pharmacokinetic study. Ten healthy participants will be admitted in the inpatient ward to receive a single oral dose of IVM (400 µg/kg). Another 10 healthy participants will be donate blood up to 42 ml each times for up to 3 times. There is no drug administration for these participants. The total duration for each volunteer's participation in the study is approximately 2 months.
HEALTHY PARTICIPANT FOR CLINICAL TRIAL Study will enroll 10 Thai healthy participants, 5 male and 5 female, aged 18-60 years. Participants will be admitted in the inpatient ward to receive a single oral dose of IVM (400 µg/kg). After a volunteert has provided written informed consent, the investigator will determine if the volunteer is eligible for enrollment in the study. This will be done by reviewing the inclusion and exclusion criteria and completing all of the screening assessments. Screening assessments may be carried out over more than one day, provided that all required assessments are completed within the 14 days prior to admission for Ivermectin administration. The blood collection for Standard Membrane Feeding Assay, Direct Feeding Assays, Pharmacokinetic analysis, Plasma for Plasmodium assays and mosquito IgG assays should be obtained at the scheduled times relative to when the participant was dosed. The total duration for each volunteer's participation in the study is approximately 2 months. HEALTHY PARTICIPANT FOR BLOOD DONOR Study will enroll 10 healthy participants, aged 18-60 years. Each participant will donate blood up to 42 ml via venipuncture up to three blood donations. There will be at least 28 days between each blood donation from the same subject. Blood will be maintained at 37°C in a warm water bath until mixed with ivermectin compounds or metabolites by Pharmacology staff and fed to mosquitoes by Armed Forces Research Institute of Medical Sciences (AFRIMS) staff. Any remaining blood after SMFAs will be discarded. No blood samples will be transferred to AFRIMS. Participants for blood donation should not be the same participants enrolled in the clinical trial above. ;
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