Working… Menu

Pediatric Pharmacokinetics And Safety Study Of Moxidectin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01035619
Recruitment Status : Withdrawn
First Posted : December 21, 2009
Last Update Posted : March 29, 2012
World Health Organization
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Onchocerciasis Drug: moxidectin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center, Open-Label, Single-Dose Study To Assess The Pharmacokinetics, Safety, And Tolerability Of Moxidectin In Subjects Aged 4 To 11 Years ( >=12 kg) With Or Without Onchocerca Volvulus Infection
Study Start Date : April 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Moxidectin

Arm Intervention/treatment
Experimental: Moxidectin Drug: moxidectin
Single Dose Moxidectin 4 mg

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01035619

Sponsors and Collaborators
World Health Organization
Layout table for investigator information
Study Director: Pfizer Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer Identifier: NCT01035619    
Other Study ID Numbers: B1751005
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012
Keywords provided by Pfizer:
onchocerciasis; river blindness; moxidectin; pediatric
Additional relevant MeSH terms:
Layout table for MeSH terms
Spirurida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents