Pediatric Pharmacokinetics And Safety Study Of Moxidectin
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
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2009
CompletedFirst Posted
Study publicly available on registry
December 21, 2009
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMarch 29, 2012
March 1, 2012
Same day
December 17, 2009
March 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
3 months
Secondary Outcomes (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
6 months
Study Arms (1)
Moxidectin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female subjects aged 4 to 11 years, inclusive (weighing \>= 12 kg)
- With or without O volvulus infection
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- World Health Organizationcollaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2009
First Posted
December 21, 2009
Study Start
April 1, 2011
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
March 29, 2012
Record last verified: 2012-03