Pediatric Pharmacokinetics And Safety Study Of Moxidectin

Pfizer

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Onchocerciasis

Interventions

moxidectinDRUG

Single Dose Moxidectin 4 mg

Eligibility

Sex: ALLMin age: 4 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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