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.

Chronic Pain Clinical Trial

Official title:

A Phase 1, Open Label Study To Investigate The Pharmacokinetics Of Multiple Doses Of PF-04531083 Tablets In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119235
• Other study ID #: B1351005
• Status: Completed
• Phase: Phase 1
• First received: April 19, 2010
• Last updated: August 5, 2010
• Start date: May 2010
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belguim: Belgian Health Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Young

• Healthy volunteers

Exclusion Criteria:

• Elderly volunteers

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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
• 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

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of PF-04531083 in blood just before dosing on the 8th day of the study		Days 1 and 8 of the study	No
Secondary	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	No

External Links

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