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

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

NCT03962062•Medicines Development for Global Health

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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

Age

4 - 17 years

Sex

ALL

Healthy Volunteers

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;
+15 more criteria

Locations (1)

University of Health and Allied Services School of Public Health

Hohoe, Volta Region, Ghana

Key Dates

Start Date

March 29, 2021

Primary Completion Date

May 30, 2022

Completion Date

September 28, 2022

Last Updated

September 5, 2025

Enrollment

ACTUAL participants

Conditions

Onchocerciasis

Interventions

Moxidectin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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