Back to resultsA 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.
Primary Purpose
Chronic Pain
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
PF-04531083
PF-04531083
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Pharmacokinetics, tablet performance, healthy volunteers, open label
Eligibility Criteria
Inclusion Criteria:
- Young
- Healthy volunteers
Exclusion Criteria:
- Elderly volunteers
- Patients with any existing medical conditions considered likely to impinge on study execution
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cohort 1: PF-04531083
Cohort 2: PF-04531083
Arm Description
Outcomes
Primary Outcome Measures
concentration of PF-04531083 in blood just before dosing on the 8th day of the study
Secondary Outcome Measures
pharmacokinetic parameters derived from the plasma concentration versus time profile of PF-04531083 following single and multiple dosing. AUCtau, Cmax, Tmax will be calculated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01119235
Brief Title
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.
Official Title
A Phase 1, Open Label Study To Investigate The Pharmacokinetics Of Multiple Doses Of PF-04531083 Tablets In Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Pharmacokinetics, tablet performance, healthy volunteers, open label
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: PF-04531083
Arm Type
Active Comparator
Arm Title
Cohort 2: PF-04531083
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04531083
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
PF-04531083
Intervention Description
Dosed as a tablet in 100mg strengths. Dosage in this optional second cohort will be optimised based on the data arising from Cohort 1
Primary Outcome Measure Information:
Title
concentration of PF-04531083 in blood just before dosing on the 8th day of the study
Time Frame
Days 1 and 8 of the study
Secondary Outcome Measure Information:
Title
pharmacokinetic parameters derived from the plasma concentration versus time profile of PF-04531083 following single and multiple dosing. AUCtau, Cmax, Tmax will be calculated.
Time Frame
Days 1, 8 and 14 of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Young
Healthy volunteers
Exclusion Criteria:
Elderly volunteers
Patients with any existing medical conditions considered likely to impinge on study execution
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1351005&StudyName=A%20Study%20To%20Observe%20The%20Performance%20Of%20A%20Tablet%20Form%20Of%20PF-04531083%20As%20Evidenced%20By%20The%20Concentration%20Of%20PF-04531083%20In%20The%20Blood%20W
Description
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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.
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