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

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ClinicalTrials.gov Identifier: NCT03962062
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
Medicines Development for Global Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Onchocerciasis Drug: Moxidectin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Moxidectin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve of moxidectin [ Time Frame: Pre-dose to Day 28 ]
    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.


Secondary Outcome Measures :
  1. Area under the concentration versus time curve (zero to infinity) of moxidectin [ Time Frame: Pre-dose to Week 12 ]
    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.

  2. Maximum observed plasma concentrations (Cmax) of moxidectin [ Time Frame: Hour 0 to Hour 8 ]
    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.

  3. Incidence and severity of adverse events [ Time Frame: Day 0 to Week 24 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962062


Contacts
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Contact: Sally Kinrade +6139912 2400 sally.kinrade@medicinesdevelopment.com
Contact: Melinda Lowe, PhD +6139912 2400 melinda.lowe@medicinesdevelopment.com

Locations
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Ghana
University of Health and Allied Services School of Public Health Recruiting
Hohoe, Volta Region, Ghana
Contact: Nicholas O Opoku, MB Ch B, MSc    +233 362 722 042    noopoku@uhas.edu.gh   
Principal Investigator: Nicholas O Opoku, MB Ch B, MSc         
Sponsors and Collaborators
Medicines Development for Global Health
Investigators
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Principal Investigator: Nicholas O Opoku, MD University of Health and Allied Sciences School of Public Health, Hohoe, Ghana
  Study Documents (Full-Text)

Documents provided by Medicines Development for Global Health:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] July 3, 2020

More Information
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Responsible Party: Medicines Development for Global Health
ClinicalTrials.gov Identifier: NCT03962062    
Other Study ID Numbers: MDGH-MOX-1006
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Onchocerciasis
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Infections
 Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Moxidectin
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents