Official Title: “A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects”

1. To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body

2. To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body

3. To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

Study Primary Completion Date: February 2009

Detailed Description:

Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration.

On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Intervention(s) in this Clinical Trial

• Drug: Metformin
  • 225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release
• Drug: Metformin
  • Single, oral, 500 mg of metformin immediate release
• Drug: PD 0332334
  • 500 mg q12, oral metformin immediate release administered on Days 1 through Day 6 Single, oral, 300 mg dose of PD 0332334 immediate release formulation administered on Day 3
• Drug: PD 0332334
  • Single, oral, 300 mg dose of PD 0332334 immediate release formulation

Arms, Groups and Cohorts in this Clinical Trial

• Other: Cohort 1
  • This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
• Other: Cohort 2
  • This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults

Primary Measures

• Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)
  • Time Frame: Days 1 through 7
    Safety Issue?: No
• Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
  • Time Frame: Days 1 through 7
    Safety Issue?: No
• Metformin and PD 0332334 half-life (t1/2)
  • Time Frame: Days 1 through 7
    Safety Issue?: No
• Metformin and PD 0332334 maximum plasma concentration
  • Time Frame: Days 1 through 7
    Safety Issue?: No

Secondary Measures

• Clinical safety laboratories
  • Time Frame: Days 1 through 7
    Safety Issue?: Yes
• Incidence, duration and severity of adverse events when study medications administered alone and concurrently
  • Time Frame: Days 1 through 7
    Safety Issue?: Yes
• Discontinuation due to adverse events when study medications administered alone and concurrently
  • Time Frame: Days 1 through 7
    Safety Issue?: Yes
• 12-lead ECGs
  • Time Frame: Days 1 through 7
    Safety Issue?: Yes
• Vital signs
  • Time Frame: Days 1 through 7
    Safety Issue?: Yes

Inclusion Criteria:

• Nonsmokers
• Male or female adults

Exclusion Criteria:

• Current or history of significant medical illness
• Smokers
• Illicit drug use

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 55 Years

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

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00809536

Study ID Number: A5361031

ClinicalTrials.gov Identifier: NCT00809536

Health Authority: United States: Food and Drug Administration

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