A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Chi… (NCT03962062) | Clinical Trial Compass
CompletedPhase 1
A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
Ghana36 participantsStarted 2021-03-29
Plain-language 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.
Who can participate
Age range4 Years – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
What they're measuring
1
Area Under the Plasma Concentration Versus Time Curve of Moxidectin.
Timeframe: Pre-dose (Screening) and post-dose at Hours 1, 2, 4, 8, 24 and 72 and Days 7, 14 and 28.