PACTR201907565746388
Completed
Phase 1
An open-label study of the pharmacokinetics and safety of a single dose of moxidectin per oral in subjects aged 4 to 17 years with (or at risk of) onchocerciasis to identify an optimal dose for treatment of children 4 to 11 years
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Onchocerciasis
- Sponsor
- Medicines Development for Global Health
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged 4 to 17 years, inclusive:
- •Cohort I: 12 to 17 years;
- •Cohort II: 8 to 11 years;
- •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, 2017\). 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 as appropriate;
- •5\. Females of childbearing potential must commit to using a reliable method of contraception as per local family planning guidelines from Screening until 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 Screening, whichever is longer;
- •4\. Has received ivermectin or any other anti\-helminthic treatments within 28 days of Screening;
- •5\. Has received a vaccination within 7 days of Screening;
- •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;
- •9\. Weight:
- •Cohort I (12 to 17 years): \< 30 kg
Outcomes
Primary Outcomes
Not specified
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