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

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.