Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults
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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
November 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMay 4, 2011
May 1, 2011
1.1 years
November 12, 2008
May 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of safety and tolerability of PF-04287881 after single oral dose.
Daily up to discharge, follow-up 7-10 days after dosing
Secondary Outcomes (1)
Pharmacokinetics of PF-04287881 after a single oral dose.
Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.
Study Arms (10)
Cohort 1
EXPERIMENTALCohort 2
EXPERIMENTALCohort 3
EXPERIMENTALCohort 4
EXPERIMENTALCohort 5
EXPERIMENTALCohort 6
EXPERIMENTALCohort 7
EXPERIMENTALCohort 8
EXPERIMENTALJapanese volunteers, low dose previously tested (based on PK)
Cohort 9
EXPERIMENTALJapanese volunteers, intermediate dose previously tested (based on PK)
Cohort 10
EXPERIMENTALJapanese volunteers, high dose previously tested (based on safety)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 12, 2008
First Posted
November 18, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
May 4, 2011
Record last verified: 2011-05