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Pediatric Pharmacokinetics And Safety Study Of Moxidectin

Primary Purpose

Onchocerciasis

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

moxidectin

About this trial

This is an interventional treatment trial for Onchocerciasis focused on measuring onchocerciasis; river blindness; moxidectin; pediatric

Eligibility Criteria

4 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Moxidectin

Arm Description

Outcomes

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

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

Full Information

NCT ID

NCT01035619

First Posted

December 17, 2009

Last Updated

March 27, 2012

Sponsor

Pfizer

Collaborators

World Health Organization

1. Study Identification

Unique Protocol Identification Number

NCT01035619

Brief Title

Pediatric Pharmacokinetics And Safety Study Of Moxidectin

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 Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Withdrawn

Study Start Date

April 2011 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

World Health Organization

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Onchocerciasis

Keywords

onchocerciasis; river blindness; moxidectin; pediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moxidectin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

moxidectin

Intervention Description

Single Dose Moxidectin 4 mg

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1751005&StudyName=Pediatric%20Pharmacokinetics%20And%20Safety%20Study%20Of%20Moxidectin

Description

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Pediatric Pharmacokinetics And Safety Study Of Moxidectin

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