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

This study has been terminated.
(Please see Detailed Description for termination reason.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00800280
First received: December 1, 2008
Last updated: February 16, 2010
Last verified: February 2010

December 1, 2008
February 16, 2010
January 2009
February 2009   (final data collection date for primary outcome measure)
  • PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf) [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]
  • PD 0332334 AUC from 0 to last quantifiable concentration (AUClast) [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]
  • Half-life (t1/2) of PD 0332334 [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of PD 0332334 [ Time Frame: 4 to 6 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00800280 on ClinicalTrials.gov Archive Site
  • Evaluate the incidence, duration and severity of adverse events [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
  • Evaluate the discontinuation due to adverse events [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
  • Clinical safety labs [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 4 to 6 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body
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

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:

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Generalized Anxiety Disorder
  • 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.
  • Experimental: Single dose PD 0332334
    Intervention: Drug: PD 0332334
  • Experimental: Single dose PD 0332334 with steady-state cimetidine
    Interventions:
    • Drug: PD 0332334
    • Drug: cimetidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy
  • male or female adults

Exclusion Criteria:

  • Current or history of clinically significant medical illness
  • Smokers
  • Illicit drug use
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00800280
A5361030
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

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