Brief Summary

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Official Title: "A Phase 1, Open Labeled, Fixed Sequence Study To Estimate The Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers"

This study will evaluate the potential effect of CP 690,550 on the pharmacokinetics of metformin, a probe drug for organic cationic transport.

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Study Primary Completion Date: July 2011

Interventions Used in this Clinical Trial

• Drug: Metformin/CP-690,550
  • Single oral 500 mg dose of metformin on Days 1 and 4 and multiple oral 30 mg doses of CP-690,550 every 12 hours on Days 2-4.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Metformin/CP-690,550

Outcome Measures for this Clinical Trial

Primary Measures

• AUCinf (Area under the plasma concentration-time profile from time zero extrapolated to infinite time) of metformin
  • Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
    Safety Issue?: No
• Cmax (Maximum plasma concentration) of metformin
  • Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
    Safety Issue?: No
• Clr (Renal clearance) of metformin
  • Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
    Safety Issue?: No

Secondary Measures

• AUClast (Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration) of metformin
  • Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
    Safety Issue?: No
• t½ (Terminal half-life) of metformin
  • Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
    Safety Issue?: No
• Tmax (Time for maximum plasma concentration) of metformin
  • Time Frame: 0.5, 1.5, 2, 3, 4, 6, 8, 9, 10, 12 and 24 hours after the metformin dose on Day 4
    Safety Issue?: No
• Ae24 (Cumulative amount of drug recovered unchanged in urine from time zero to 24 hours postdose) of metformin
  • Time Frame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4
    Safety Issue?: No
• Ae24% (Percent of dose recovered unchanged in urine from time zero to 24 hours postdose) of metformin
  • Time Frame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4
    Safety Issue?: No
• Clr (Renal clearance) over each collection interval for metformin
  • Time Frame: 0 hours and intervals 0-3, 3-6, 6-9, 9-12 and 12 24 hours after the metformin dose on Day 4
    Safety Issue?: No
• CP-690,550 plasma concentration at 2 hours postdose
  • Time Frame: 2 hrs after first CP-690,550 dose on Day 4
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Adult healthy male and/or female (of non child bearing potential) subjects.

Exclusion Criteria

• Subjects with clinically significant systemic and laboratory abnormalities.
• Subjects with clinically significant infections within the past 3 months.
• Women of child-bearing potential.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

• Lead Sponsor
  • Pfizer
• Provider of Information About this Clinical Study
  • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Overall Official(s)
  • Pfizer CT.gov Call Center, Study Director, Pfizer