Pediatric Pharmacokinetics And Safety Study Of Moxidectin
NCT01035619
ABOUT THIS STUDY
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- Male or female subjects aged 4 to 11 years, inclusive (weighing >= 12 kg)
- With or without O volvulus infection
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Pediatric Pharmacokinetics And Safety Study Of Moxidectin | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Onchocerciasis | |||
Intervention ICMJE | Drug: moxidectin
Single Dose Moxidectin 4 mg | |||
Study Arms ICMJE | Experimental: Moxidectin
Intervention: Drug: moxidectin | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE | 0 | |||
Original Estimated Enrollment ICMJE | 36 | |||
Actual Study Completion Date ICMJE | April 2011 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 4 Years to 11 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01035619 | |||
Other Study ID Numbers ICMJE | B1751005 3110A1-2201 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | World Health Organization | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |