Pediatric Pharmacokinetics And Safety Study Of Moxidectin
- Registration Number
- NCT01035619
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Male or female subjects aged 4 to 11 years, inclusive (weighing >= 12 kg)
- With or without O volvulus infection
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Moxidectin moxidectin -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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