a pharmacokinetic and safety study of moxidectin to identify an optimal dose for treatment of children 4 to 11 years

Conditions: Onchocerciasis

Summary: the primary purpose of this study is to determine a dose of moxidectin for children 4 to 11 years that is equivalent to an 8 mg dose administered for treatment of onchocerciasis in people 12 years and over. the secondary purpose is to evaluate the safety and pharmacokinetics of a single dose of moxidectin in children and adolescents aged 4 to 17 years.


Eligibility criteria:
inclusion criteria: 1. aged 4 to 17 years, inclusive: 1. cohort i: 12 to 17 years; 2. cohort ii: 8 to 11 years; 3. cohort iii: 4 to 7 years; 2. live in a region designated by the world health organization (who) as endemic for o. volvulus infection (world health organization, 2019). specifically, participants will be recruited from the kpassa sub-district of the nkwanta north district.the specific communities will include wii, jagri-do, and azua where mass drug administration with ivermectin for onchocerciasis commenced in october 2017; 3. willing and able to remain at the study clinic from screening up to day 7; 4. provision of parental or guardian written informed consent and assent / lack of expression of 'deliberate objection' (as appropriate for age); 5. females of childbearing potential must commit to using a reliable method of contraception as per local family planning guidelines from baseline (pre-treatment on day 0) until approximately 6 months after treatment with study drug. exclusion criteria: 1. history of serious medical or psychiatric condition which, in the opinion of the investigator, would put the subject at increased risk by participating in the study or jeopardize study outcomes; 2. known or suspected concurrent clinically significant renal, cardiac, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunological disorders or malignancy, congenital heart disease, chronic lung disease; 3. has received an investigational product within 28 days or 5 half-lives of baseline, whichever is longer; 4. has received ivermectin or any other anti-helminthic treatments within 28 days of baseline; 5. has received a vaccination within 7 days of baseline; 6. known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin; 7. poor venous access; 8. unable to swallow tablets (flat oval, 8.0 millimeters (mm) x 4.5 mm x 3.0 mm); 9. weight: 1. cohort i (12 to 17 years): \< 30 kg; 2. cohort ii (8 to 11 years): \< 18 kg; 3. cohort iii (4 to 7 years): \< 12 kg; 10. clinically relevant laboratory abnormalities at screening, including: 1. hemoglobin \< 9.5 grams per deciliter (g/dl); 2. neutrophil (granulocyte) count \< 1.5 x 109/l; 3. platelet count \< 110 x 109/l; 4. alanine aminotransferase (alt) \> 1.5 times the upper limit of normal range (uln); 5. total bilirubin \> 1.5 times uln; 11. hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) positive; 12. known or suspected malaria or other ongoing viral, bacterial, or plasmodium infection at screening and/or baseline; 13. loa loa co-infection; 14. unwilling, unlikely or unable to comply with all protocol specified assessments; 15. for females of child bearing potential, pregnant or breastfeeding, or planning to become pregnant; 16. previous enrolment in this study; 17. is a sibling of another child already enrolled in this study.