Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

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NCT00800280

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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1-800-718-1021
[email protected]fizer.com
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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
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- healthy

- 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 clinically significant medical illness


- Smokers


- Illicit drug use

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body
Official Title  ICMJE A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects
Brief Summary The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.
Detailed Description

Detailed Description:

Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334.

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: PD 0332334
    Single 300 mg dose of PD 0332334 immediate release capsules administered orally
    Other Name: imagabalin
  • Drug: PD 0332334
    Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.
  • Drug: cimetidine
    600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.
Study Arms  ICMJE
  • Experimental: Single dose PD 0332334
    Intervention: Drug: PD 0332334
  • Experimental: Single dose PD 0332334 with steady-state cimetidine
    Interventions:
    • Drug: PD 0332334
    • Drug: cimetidine
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 1, 2008)		12
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:

  • healthy
  • male or female adults

Exclusion Criteria:

  • Current or history of clinically significant medical illness
  • Smokers
  • Illicit drug use
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800280
Other Study ID Numbers  ICMJE A5361030
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