Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults
NCT00793000
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
- Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
- Women of non-childbearing potential only.
- Japanese subjects muct have 4 Japanese grandparents who were born in Japan.
- Previous antibiotic use within 14 days prior to dosing.
- Use of antibiotics during hospitalization within 90 days prior to dosing.
- History of sensitivity to macrolides or ketolides.
- Presence of clinically significant eye conditions (other than corrective lenses).
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Descriptive Information | ||||
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Brief Title ICMJE | Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults | |||
Official Title ICMJE | A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After First Time Administration Of Ascending Single Oral Doses To Healthy Adult Subjects | |||
Brief Summary | The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) | |||
Condition ICMJE | Respiratory Tract Infections | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 80 | |||
Original Estimated Enrollment ICMJE | 72 | |||
Actual Study Completion Date ICMJE | December 2009 | |||
Actual Primary Completion Date | December 2009 (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 | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00793000 | |||
Other Study ID Numbers ICMJE | B0581001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | May 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |