Pediatric Pharmacokinetics And Safety Study Of Moxidectin

• Status: Withdrawn
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Collaborator: World Health Organization
• Treatments: Milbemycin; Moxidectin

Criteria

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