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.

• ClinicalTrials.gov Identifier: NCT01119235
• Recruitment Status: Completed
• First Posted: May 7, 2010
• Last Update Posted: August 6, 2010
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: April 19, 2010
• First Posted Date: May 7, 2010
• Last Update Posted Date: August 6, 2010
• Study Start Date: May 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 5, 2010): 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 ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01119235 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: May 5, 2010): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Pain

Intervention

• 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
• 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

Study Arms

• Active Comparator: Cohort 1: PF-04531083
  Intervention: Drug: PF-04531083
• Active Comparator: Cohort 2: PF-04531083
  Intervention: Drug: PF-04531083

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2010): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Young
• Healthy volunteers

Exclusion Criteria:

• Elderly volunteers
• Patients with any existing medical conditions considered likely to impinge on study execution

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01119235
• Other Study ID Numbers: B1351005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: August 2010