Open-Label Study to Evaluate Pharmacokinetic Properties and Mosquito-Lethal Effect of Ivermectin Metabolites in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Oxford
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Terminal elimination half-life for Ivermectin and its metabolites
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Healthy volunteer for Clinical Trial
Intervention: Ivermectin (Drug)
Outcomes
Primary Outcomes
Terminal elimination half-life for Ivermectin and its metabolites
Time Frame: 41 days
Pharmacokinetic parameters (terminal elimination half-life \[t1/2\]) for Ivermectin and its metabolites.
Area under the concentration-time curve for Ivermectin and its metabolites
Time Frame: 41 days
Pharmacokinetic parameters (area under the concentration-time curve \[(AUC∞ and AUCLAST\] for Ivermectin and its metabolites.
Maximum concentration for Ivermectin and its metabolites
Time Frame: 41 days
Pharmacokinetic parameters (maximum concentration \[CMAX\]) for Ivermectin and its metabolites.
Time to maximum concentration for Ivermectin and its metabolites
Time Frame: 41 days
Pharmacokinetic parameters (time to maximum concentration \[TMAX\]) for Ivermectin and its metabolites.
Concentration associated with half maximum mosquito killing effect [LC50] for Ivermectin and its metabolites
Time Frame: 41 days
Pharmacodynamic parameters (concentration associated with half maximum mosquito killing effect \[LC50\]) for Ivermectin and its metabolites.
Secondary Outcomes
- Compare mosquito (An. dirus) survival curves to day 14 between Direct Feeding Assay and Standard Membrane Feeding Assays(14 days)
- The lethal concentration that kills 50% of mosquitoes (LC50) between two strains of An. dirus(14 days)
- Duration of mosquito survivorship(14 days)
- Compare mosquito (An. Minimus) survival curves to day 14 between Direct Feeding Assay and Standard Membrane Feeding Assays(14 days)
- Mosquito survival curves to day 14 between two strains of An. dirus.(14 days)
- Compare Maximum Blood Concentrations (Cmax) for ivermectin components and metabolites measured between venous and capillary blood(41 days)
- The inhibitory concentration that kills 50% of parasites (IC50) for each P. falciparum strain.(48 hours)
- Compare Area-Under-Curve (AUC) for ivermectin components and metabolites measured between venous and capillary blood(41 days)
- The lethal concentration that kills 50% of mosquitoes (LC50) for each ivermectin component and synthesized metabolites(14 days)