A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.
A Phase 1, Open Label Study To Investigate The Pharmacokinetics Of Multiple Doses Of PF-04531083 Tablets In Healthy Volunteers
1 other identifier
interventional
24
1 country
1
Brief Summary
A new tablet form of PF-04531083 has been manufactured. Previously the compound was administered as a solution/suspension to healthy volunteers. This study will investigate the pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics obtained, with the same dosing regimen, with the solution/suspension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 chronic-pain
Started May 2010
Shorter than P25 for phase_1 chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedFirst Posted
Study publicly available on registry
May 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedAugust 6, 2010
August 1, 2010
2 months
April 19, 2010
August 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
concentration of PF-04531083 in blood just before dosing on the 8th day of the study
Days 1 and 8 of the study
Secondary Outcomes (1)
pharmacokinetic parameters derived from the plasma concentration versus time profile of PF-04531083 following single and multiple dosing. AUCtau, Cmax, Tmax will be calculated.
Days 1, 8 and 14 of the study
Study Arms (2)
Cohort 1: PF-04531083
ACTIVE COMPARATORCohort 2: PF-04531083
ACTIVE COMPARATORInterventions
Dosed as a tablet in 100mg strengths. Dosage in the first cohort will be 300mg twice daily for 3 days followed by 200mg twice daily for 11 days
Eligibility Criteria
You may qualify if:
- Young
- Healthy volunteers
You may not qualify if:
- Elderly volunteers
- Patients with any existing medical conditions considered likely to impinge on study execution
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, 1070, Belgium
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 19, 2010
First Posted
May 7, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
August 6, 2010
Record last verified: 2010-08