Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects
NCT ID: NCT01026545
Last Updated: 2011-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2009-12-31
2010-07-31
Brief Summary
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Approximately 60 healthy volunteers (20 volunteers of Japanese origin for Cohorts 5 and 6), 18 to 55 years of age, males and females (women of non childbearing potential only) will be enrolled and randomized in a 4:1 ratio to treatment with either PF-04287881 or placebo within each cohort. Each cohort will have a 10 day dosing period and each will consist of 10 subjects (8 active and 2 placebo). In each cohort, each subject will receive a single daily oral dose of either placebo or PF-04287881 under fasted state for 10 days.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Cohort 1
PF-04287881
500 mg once daily for 10 days
Placebo
To match 500 mg dose once daily for 10 days
Cohort 2
PF-04287881
750 mg once daily for 10 days
Placebo
To match 750 mg dose once daily for 10 days
Cohort 3
PF-04287881
1100 mg once daily for 10 days
Placebo
To match 1100 mg dose once daily for 10 days
Cohort 4 (optional)
If intermediate or repeat dose level is needed; dose will not exceed 1100 mg.
PF-04287881
Optional cohort with dose not greater than 1100 mg
Placebo
Optional cohort to match dose not greater than 1100 mg
Cohort 5 (Japanese)
PF-04287881
750 mg dose once daily for 10 days
Placebo
To match 750 mg dose once daily for 10 days
Cohort 6 (Japanese)
PF-04287881
1100 mg dose once daily for 10 days
Placebo
To match 1100 mg dose once daily for 10 days
Interventions
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PF-04287881
500 mg once daily for 10 days
Placebo
To match 500 mg dose once daily for 10 days
PF-04287881
750 mg once daily for 10 days
Placebo
To match 750 mg dose once daily for 10 days
PF-04287881
1100 mg once daily for 10 days
Placebo
To match 1100 mg dose once daily for 10 days
PF-04287881
Optional cohort with dose not greater than 1100 mg
Placebo
Optional cohort to match dose not greater than 1100 mg
PF-04287881
750 mg dose once daily for 10 days
Placebo
To match 750 mg dose once daily for 10 days
PF-04287881
1100 mg dose once daily for 10 days
Placebo
To match 1100 mg dose once daily for 10 days
Eligibility Criteria
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Inclusion Criteria
* Women of non-childbearing potential only.
* Japanese subjects must have 4 Japanese grandparents who were born in Japan.
Exclusion Criteria
* Use of antibiotics during hospitalization within 90 days prior to dosing.
* History of hypersensitivity to macrolides or ketolides.
* Presence of clinically significant eye conditions (other than corrective lenses).
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
New Haven, Connecticut, United States
Countries
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Related Links
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Other Identifiers
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B0581002
Identifier Type: -
Identifier Source: org_study_id
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