Onchocerciasis
Conditions
Keywords
onchocerciasis; river blindness; moxidectin; pediatric
Brief summary
The purpose of this study is to measure the amount of moxidectin in subjects' blood and to measure safety. This study will enroll 36 children aged 4 to 11 years (\>=12 kg) with or without Onchocerca volvulus (O volvulus) infection. O volvulus is the nematode, or roundworm, that causes Onchocerciasis, also known as river blindness. Each subject will receive a single dose of 4 mg moxidectin (orally administered) and will be followed inpatient from screening through day 13 and as outpatients through month 6. The study will take place at a single research center.
Interventions
DRUGmoxidectin
Single Dose Moxidectin 4 mg
Sponsors
World Health Organization
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects aged 4 to 11 years, inclusive (weighing \>= 12 kg) * With or without O volvulus infection
Exclusion criteria
* Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study * Contraindication or hypersensitivity to moxidectin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of moxidectin in subjects blood, as measured by collecting a number of blood samples from each subject, in which the amount of moxidectin will be measured | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| The safety and tolerability of a single dose of 4 mg moxidectin in subjects as measured by physical examinations, laboratory tests, vital signs and ECG findings | 6 months |
Outcome results
None listed