Clinical Trial: Pediatric Pharmacokinetics And Safety Study Of Moxidectin

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: 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

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 Summary:
Sponsor: Pfizer

Current Primary Outcome: 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 [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: December 17, 2009
Date Started: April 2011
Date Completion:
Last Updated: March 27, 2012
Last Verified: March 2012