Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin

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NCT00736697

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Study Location
Poitiers, , 86000, France
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Men or women of non childbearing potential aged 18 to 50 years inclusive at screening.

- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any clinical important deviation from normal limits in physical examination findings,
vital sign measurements, electrocardiograms or clinical laboratory test results.


- Presence or history of any disorder that may prevent the successful completion of the
study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin
Official Title  ICMJE An Open-Label, Randomized, Single-Dose, Parallel-Group Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Moxidectin Administered Orally to Healthy Subjects
Brief Summary The primary objective of this study is to assess the effect of a high-fat meal (breakfast) on the concentrations of moxidectin measured in the blood after a single oral administration in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Infection
Intervention  ICMJE Drug: moxidectin
Study Arms  ICMJE Experimental: 1
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2008)		54
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Men or women of non childbearing potential aged 18 to 50 years inclusive at screening.
  • Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion criteria

  • Any clinical important deviation from normal limits in physical examination findings, vital sign measurements, electrocardiograms or clinical laboratory test results.
  • Presence or history of any disorder that may prevent the successful completion of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00736697
Other Study ID Numbers  ICMJE 3110A1-1005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP