NCT01035619

Pediatric Pharmacokinetics And Safety Study Of Moxidectin

A Single-Center, Open-Label, Single-Dose Study To Assess The Pharmacokinetics, Safety, And Tolerability Of Moxidectin In Subjects Aged 4 To 11 Years ( >=12 kg) With Or Without Onchocerca Volvulus Infection

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Onchocerciasis

Interventions

Type	Name	Description
DRUG	moxidectin	Single Dose Moxidectin 4 mg

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-12-21
• Last updated: 2012-03-29