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NCT01035619 Clinical Trial

Pediatric Pharmacokinetics And Safety Study Of Moxidectin

Onchocerciasis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01035619
Other study ID # B1751005
Secondary ID 3110A1-2201
Status Withdrawn
Phase Phase 2
First received December 17, 2009
Last updated March 27, 2012
Start date April 2011
Est. completion date April 2011

Study information
Verified date March 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Ghana : Food and Drugs Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years to 11 Years
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• moxidectin
Single Dose Moxidectin 4 mg

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Pfizer World Health Organization

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 Yes
See also
  Status Clinical Trial Phase
Completed NCT00300768 - Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection Phase 2
Not yet recruiting NCT04035174 - Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa N/A
Recruiting NCT03653975 - Clinical Features and Potential Etiology of Epilepsy and Nodding Syndrome in the Mahenge Area, Ulanga District
Completed NCT03052998 - Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy Phase 4
Recruiting NCT04311671 - Safety of a Single Dose of Moxidectin Compared With Ivermectin in Individuals Living in Onchocerciasis Endemic Areas and in Individuals Living in Onchocerciasis Endemic Areas With High Levels of Lymphatic Filariasis Co-endemicity Receiving Concomitant Albendazole Phase 3
Active, not recruiting NCT03876262 - Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis Phase 3
Terminated NCT04913610 - Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-4083 Capsules When Given Alone or In Combination With Albendazole Capsules Moves in The Body of Adult Participants With Onchocerca Volvulus Infection Phase 2
Completed NCT03962062 - A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years Phase 1
Completed NCT01905436 - Mass Drug Administration for Lymphatic Filariasis and Onchocerciasis for Liberia
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Completed NCT05750043 - Effect of Onchocerciasis Elimination Measures on the Incidence of Epilepsy in Maridi, South Sudan
Completed NCT05749653 - Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area N/A
Completed NCT02078024 - Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana Phase 3
Completed NCT00127504 - Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness Phase 2
Completed NCT03131401 - Prevalence of LF Infection in Districts Not Included in LF Control Activities
Not yet recruiting NCT06070116 - Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis Phase 2
Completed NCT02032043 - Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast (DOLF-Ivory Coast)
Completed NCT04188301 - Safety and Efficacy of IDA for Onchocerciasis Phase 2
Terminated NCT05084560 - Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug Phase 1
Completed NCT03517462 - Ocular Changes After Ivermectin - (DOLF IVM/Oncho) N/A

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