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Determination of a Dose of Moxidectin in Individuals < 12 Years of Age

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ClinicalTrials.gov Identifier: NCT03962062
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Medicines Development Limited

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Moxidectin

Arm Intervention/treatment
Experimental: Cohort 1: 12-17 years
Moxidectin 8mg per oral, single dose
Drug: Moxidectin
2mg tablets

Experimental: Cohort 2: 8-11 years
Moxidectin 8mg (or lower dose) per oral, single dose
Drug: Moxidectin
2mg tablets

Experimental: Cohort 3: 4-7 years
Moxidectin single dose, determined by population pharmacokinetic modelling including data from Cohorts 1 and 2
Drug: Moxidectin
2mg tablets




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.



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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, 2017). 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 as appropriate;
  5. Females of childbearing potential must commit to using a reliable method of contraception as per local family planning guidelines from Screening until 6 months after treatment with study drug;
  6. Test positive for O. volvulus immunoglobulin G4 (OV16 IgG4) antibody by rapid format antibody card test.

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 Screening, whichever is longer;
  4. Has received ivermectin or any other anti-helminthic treatments within 28 days of Screening;
  5. Has received a vaccination within 7 days of Screening;
  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;
  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

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 +61396296111 sally.kinrade@medicinesdevelopment.com

Sponsors and Collaborators
Medicines Development Limited

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Responsible Party: Medicines Development Limited
ClinicalTrials.gov Identifier: NCT03962062     History of Changes
Other Study ID Numbers: MDGH-MOX-1006
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: April 2019
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
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Milbemycin
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents