Pediatric Pharmacokinetics And Safety Study Of Moxidectin

• Sponsor: Pfizer (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01035619
• Collaborator: World Health Organization (Other)
• Enrollment: 0
• Arm: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Onchocerciasis	Drug: moxidectin	Phase 2

Study Design

• Study Type: Interventional
• 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: Apr 1, 2011
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

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

Outcome Measures

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 [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 [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 11 Years
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer
• World Health Organization

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01035619
• Other Study ID Numbers: B1751005; 3110A1-2201
• First Posted: Dec 21, 2009
• Last Update Posted: Mar 29, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Pfizer: onchocerciasis; river blindness; moxidectin; pediatric
• Additional relevant MeSH terms: Onchocerciasis; Moxidectin

Study Results

No Results Posted as of Mar 29, 2012