Pediatric Pharmacokinetics and Safety Study of Moxidectin

2014-08-27 03:17:11 | BioPortfolio


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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment






Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:17:11-0400

Clinical Trials [13 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura

The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will...

Study Evaluating Orally Administered Moxidectin in Subjects With Onchocerca Volvulus Infection

The purpose of this study is to determine the safety, tolerability, efficacy and pharmacokinetics of orally administered moxidectin in subjects with onchocerca volvulus infection.

Effect of a Single Oral Dose of Moxidectin on the Cardiac QT Interval of Healthy Volunteers

This study will investigate the effect of a single oral dose of moxidectin on the QT interval associated with moxidectin plasma concentrations. The effect of moxidectin on other ECG inter...

Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women

The purpose of this study is to evaluate the extent of moxidectin transfer into the breast milk of lactating women and to provide the initial pharmacokinetic and safety profile of moxidect...

Study Evaluating The Co-Administration Of Moxidectin And Midazolam In Healthy Subjects

The purpose of this study is to evaluate the effect of single doses of midazolam on the plasma concentration of a single dose of moxidectin in healthy young adult subjects, and to assess t...

PubMed Articles [26 Associated PubMed Articles listed on BioPortfolio]

Update on the current status of onchocerciasis in Côte d'Ivoire following 40 years of intervention: Progress and challenges.

Onchocerciasis control in Côte d'Ivoire started with aerial insecticide spraying in 1974 and continued with community directed treatment with ivermectin (CDTi) from 1992 to the present. Onchocerciasi...

Clinical presentations of onchocerciasis-associated epilepsy (OAE) in Cameroon.

A high prevalence of epilepsy has been observed in several onchocerciasis-endemic countries, including Cameroon. However, little is known on the clinical presentations of the affected persons with epi...

Community-directed vector control to supplement mass drug distribution for onchocerciasis elimination in the Madi mid-North focus of Northern Uganda.

Onchocerciasis a neglected tropical disease that historically has been a major cause of morbidity and an obstacle to economic development in the developing world. It is caused by infection with Onchoc...

High prevalence of onchocerciasis-associated epilepsy in villages in Maridi County, Republic of South Sudan: A community-based survey.

To determine the prevalence and incidence of epilepsy in an onchocerciasis endemic region of South Sudan.

Clinical characteristics of onchocerciasis-associated epilepsy in villages in Maridi County, Republic of South Sudan.

To describe the clinical manifestations of persons with epilepsy (PWE) in onchocerciasis endemic villages in South Sudan.

Medical and Biotech [MESH] Definitions

Several species of the genus Simulium (family Simuliidae) that act as intermediate hosts (vectors) for the parasitic disease ONCHOCERCIASIS.

Infection with nematodes of the genus ONCHOCERCA. Characteristics include the presence of firm subcutaneous nodules filled with adult worms, PRURITUS, and ocular lesions.

Diseases that are underfunded and have low name recognition but are major burdens in less developed countries. The World Health Organization has designated six tropical infectious diseases as being neglected in industrialized countries that are endemic in many developing countries (HELMINTHIASIS; LEPROSY; LYMPHATIC FILARIASIS; ONCHOCERCIASIS; SCHISTOSOMIASIS; and TRACHOMA).

Filarial infection of the eyes transmitted from person to person by bites of Onchocerca volvulus-infected black flies. The microfilariae of Onchocerca are thus deposited beneath the skin. They migrate through various tissues including the eye. Those persons infected have impaired vision and up to 20% are blind. The incidence of eye lesions has been reported to be as high as 30% in Central America and parts of Africa.

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