A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years

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.