Pediatric Pharmacokinetics And Safety Study Of Moxidectin

Pfizer

Status and phase: Withdrawn; Phase 2

Conditions: Onchocerciasis

Treatments: Drug: moxidectin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01035619

B1751005

3110A1-2201

Details and patient eligibility

About

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.

Sex: All

Ages: 4 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Moxidectin

Experimental group

Treatment:

Drug: moxidectin