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This study has been withdrawn prior to enrollment.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
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 April 17, 2014