NCT03962062

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Medicines Development for Global Health · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Onchocerciasis

Interventions

Type	Name	Description
DRUG	Moxidectin	2 mg tablets

Timeline

• Start date: 2021-03-29
• Primary completion: 2022-05-30
• Completion: 2022-09-28
• First posted: 2019-05-23
• Last updated: 2025-09-05
• Results posted: 2025-01-22

Locations

1 site across 1 country: Ghana

Regulatory

• FDA-regulated drug study