Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time

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NCT00809536

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Study Location
Pfizer Investigational Site
Singapore, , 188770, Singapore
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Nonsmokers

- Male or female adults

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Current or history of significant medical illness


- Smokers


- Illicit drug use

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Advanced Information
Descriptive Information
Brief Title  ICMJE Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time
Official Title  ICMJE A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects
Brief Summary
  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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • 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
    Other Name: imagabalin
  • 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
Study Arms  ICMJE
  • Cohort 1
    This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
    Interventions:
    • Drug: Metformin
    • Drug: Metformin
  • Cohort 2
    This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
    Interventions:
    • Drug: PD 0332334
    • Drug: PD 0332334
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 15, 2008)		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nonsmokers
  • Male or female adults

Exclusion Criteria:

  • Current or history of significant medical illness
  • Smokers
  • Illicit drug use
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809536
Other Study ID Numbers  ICMJE A5361031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP