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

Onchocerciasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962062
• Other study ID #: MDGH-MOX-1006
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2021
• Est. completion date: September 28, 2022

Study information

• Verified date: December 2022
• Source: Medicines Development for Global Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 28, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Onchocerciasis

Intervention

Drug:
• Moxidectin
2 mg tablets

Locations

Country	Name	City	State
Ghana	University of Health and Allied Services School of Public Health	Hohoe	Volta Region

Sponsors (1)

Lead Sponsor	Collaborator
Medicines Development for Global Health

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 to Day 28
Secondary	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 to Week 12
Secondary	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.	Hour 0 to Hour 8
Secondary	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