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.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01119235
First received: April 19, 2010
Last updated: August 5, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Drug: PF-04531083
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open Label Study To Investigate The Pharmacokinetics Of Multiple Doses Of PF-04531083 Tablets In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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. [ Time Frame: Days 1, 8 and 14 of the study ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1: PF-04531083 Drug: PF-04531083
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
Active Comparator: Cohort 2: PF-04531083 Drug: PF-04531083
Dosed as a tablet in 100mg strengths. Dosage in this optional second cohort will be optimised based on the data arising from Cohort 1

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Young
  • Healthy volunteers

Exclusion Criteria:

  • Elderly volunteers
  • Patients with any existing medical conditions considered likely to impinge on study execution
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119235

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01119235     History of Changes
Other Study ID Numbers: B1351005
Study First Received: April 19, 2010
Last Updated: August 5, 2010
Health Authority: Belguim: Belgian Health Authority

Keywords provided by Pfizer:
Pharmacokinetics
tablet performance
healthy volunteers
open label

ClinicalTrials.gov processed this record on April 16, 2014