You are here

Our science / Clinical Trials / Find a Trial / NCT00800280

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

Back to Search Print Save as PDF Bookmark Trial

NCT00800280

Last updated on February 17, 2020
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- 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

NCT00800280
Pfizer
Terminated
Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Advanced Search
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 Center Pfizer
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now