Pediatric Pharmacokinetics And Safety Study Of Moxidectin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Onchocerciasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moxidectin

Group Type EXPERIMENTAL

moxidectin

Intervention Type DRUG

Single Dose Moxidectin 4 mg

Interventions

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moxidectin

Single Dose Moxidectin 4 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes