Pediatric Pharmacokinetics And Safety Study Of Moxidectin

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01035619
First received: December 17, 2009
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Onchocerciasis
Drug: moxidectin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: April 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moxidectin Drug: moxidectin
Single Dose Moxidectin 4 mg

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035619

Sponsors and Collaborators
Pfizer
World Health Organization
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01035619     History of Changes
Other Study ID Numbers: B1751005, 3110A1-2201
Study First Received: December 17, 2009
Last Updated: March 27, 2012
Health Authority: Ghana : Food and Drugs Board

Keywords provided by Pfizer:
onchocerciasis; river blindness; moxidectin; pediatric

Additional relevant MeSH terms:
Onchocerciasis
Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Milbemycin
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antinematodal Agents

ClinicalTrials.gov processed this record on July 22, 2014