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

NCT03962062 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: MDGH-MOX-1006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Area Under the Concentration Versus Time Curve (Zero to Infinity) of Moxidectin

  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

  Pre-dose (Screening) and post-dose at Hours 1, 2, 4 and 8.

• Incidence and Severity of Adverse Events.

  Day 0 to Week 24 inclusive.

Study Arms (3)

Cohort 1: 12-17 years

EXPERIMENTAL

Moxidectin 8mg per oral, single dose

Drug: Moxidectin

Cohort 2: 8-11 years

EXPERIMENTAL

Moxidectin 8mg (or lower dose) per oral, single dose

Drug: Moxidectin

Cohort 3: 4-7 years

EXPERIMENTAL

Moxidectin single dose, determined by population pharmacokinetic modelling including data from Cohorts 1 and 2

Drug: Moxidectin

Interventions

Moxidectin DRUG

2 mg tablets

Cohort 1: 12-17 years; Cohort 2: 8-11 years; Cohort 3: 4-7 years

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 4 to 17 years, inclusive:
• Cohort I: 12 to 17 years;
• Cohort II: 8 to 11 years;
• Cohort III: 4 to 7 years;
• 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;
• Willing and able to remain at the study clinic from Screening up to Day 7;
• Provision of parental or guardian written informed consent and assent / lack of expression of 'deliberate objection' (as appropriate for age);
• 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.

You may not qualify if:

• 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;
• 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;
• Has received an investigational product within 28 days or 5 half-lives of Baseline, whichever is longer;
• Has received ivermectin or any other anti-helminthic treatments within 28 days of Baseline;
• Has received a vaccination within 7 days of Baseline;
• Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin;
• Poor venous access;
• Unable to swallow tablets (flat oval, 8.0 millimeters (mm) x 4.5 mm x 3.0 mm);
• Weight:
• Cohort I (12 to 17 years): \< 30 kg;
• Cohort II (8 to 11 years): \< 18 kg;
• Cohort III (4 to 7 years): \< 12 kg;
• Clinically relevant laboratory abnormalities at Screening, including:
• Hemoglobin \< 9.5 grams per deciliter (g/dL);
• Neutrophil (granulocyte) count \< 1.5 x 109/L;

Sponsors & Collaborators

• Medicines Development for Global Health: lead

Study Sites (1)

University of Health and Allied Services School of Public Health

Hohoe, Volta Region, Ghana

Location

Related Publications (1)

• 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.

  PMID: 40707999 RESULT

Related 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.

MeSH Terms

Conditions

Onchocerciasis

Interventions

moxidectin

Condition Hierarchy (Ancestors)

Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Sally Kinrade, Vice President, Project Leader, Onchocerciasis & Lymphatic Filariasis
• Organization: Medicines Development for Global Health

sally.kinrade@medicinesdevelopment.com

+61 3 9912 2400

Study Officials

• Nicholas O Opoku, MD

  University of Health and Allied Sciences School of Public Health, Hohoe, Ghana

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, age-stratified, adaptive, open-label, single-dose study with 3, age-defined cohorts. Cohort 1 (12 to 17 years, n = 9) and Cohort 2 (8 to 11 years, n = 9) will receive moxidectin 8 mg. Cohort 3 (4 to 7 years, n = 9) will receive moxidectin at a dose to be determined from safety and pharmacokinetic data analyses of Cohorts 1 and 2. If the starting dose for Cohorts 2 and 3 results in at least 3 subjects with moxidectin exposures above the target range, a revised dose will be determined in decrements of 2 mg and the Cohort(s) will be repeated with at least 9 new subjects. For Cohort 3, if the starting dose results in at least 3 subjects with moxidectin exposures below the target range, a revised dose will be determined in increments of 2 mg to a maximum dose of 8 mg.Therefore, it is expected that the study will enroll 27 subjects. However, if additional cohorts are required to meet pharmacokinetic outcomes, up to a maximum of 63 subjects may be enrolled.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: March 29, 2021
• Primary Completion: May 30, 2022
• Study Completion: September 28, 2022
• Last Updated: September 5, 2025
• Results First Posted: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available 12 months after publication.
• 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.

Locations

GH (1)