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

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.

Study Overview

• Status: Completed
• Conditions: Onchocerciasis
• Intervention / Treatment: Drug: Moxidectin

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Ghana
  • Volta Region
    • Hohoe, Volta Region, Ghana
      • University of Health and Allied Services School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: 12-17 years; Moxidectin 8mg per oral, single dose	Drug: Moxidectin; 2 mg tablets
Experimental: Cohort 2: 8-11 years; Moxidectin 8mg (or lower dose) per oral, single dose	Drug: Moxidectin; 2 mg tablets
Experimental: Cohort 3: 4-7 years; Moxidectin single dose, determined by population pharmacokinetic modelling including data from Cohorts 1 and 2	Drug: Moxidectin; 2 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Plasma Concentration Versus Time Curve of Moxidectin.	Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.	Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin	Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.	Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72, Days 7, 14 and 28 and Week 12.
Maximum Observed Plasma Concentrations (Cmax) of Moxidectin	Moxidectin concentration in plasma collected at pre-specified intervals after dosing with oral moxidectin determined using a validated liquid chromatography-mass spectrometry(MS)/MS method.	Pre-dose (Screening) and post-dose at Hours 1, 2, 4 and 8.
Incidence and Severity of Adverse Events.	Incidence and severity of adverse events, assessed by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric Adverse Events, Version 2.1.	Day 0 to Week 24 inclusive.

Collaborators and Investigators

• Sponsor: Medicines Development for Global Health
• Investigators: Principal Investigator: Nicholas O Opoku, MD, University of Health and Allied Sciences School of Public Health, Hohoe, Ghana

Publications and helpful links

General Publications

• Opoku NO, Doe F, Agbogah ME, Laryea R, Gordor SK, Donkor BS, Anyomitse E, Kugali D, van Zutphen-van Geffen M, Navarro DJ, Rayner CR, Patel K, Kuesel AC, Lowe M, Kinrade S. Identification of a moxidectin dose for 4- to 11-year-old children to support registration and potential use for onchocerciasis elimination: results of an open-label pharmacokinetic and safety study. Parasit Vectors. 2025 Jul 24;18(1):295. doi: 10.1186/s13071-025-06891-z.

Helpful Links

• Identification of a moxidectin dose for 4- to 11-year-old children to support registration and potential use for onchocerciasis elimination: results of an open-label pharmacokinetic and safety study.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): September 28, 2022

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Skin Diseases; Skin Diseases, Infectious; Spirurida Infections; Secernentea Infections; Nematode Infections; Skin Diseases, Parasitic; Helminthiasis; Filariasis; Skin and Connective Tissue Diseases; Onchocerciasis; Anti-Infective Agents; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; moxidectin
• Other Study ID Numbers: MDGH-MOX-1006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data in the form of data listings and SDTM and ADaM datasets may be available for sharing on application to the Sponsor.
• IPD Sharing Time Frame: Data will become available 12 months after publication.
• IPD Sharing Access Criteria: Provision of a methodologically sound and relevant proposal detailing the intended use of the data and relevant ethics approval for the proposed analysis, as applicable.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No