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

This study has been terminated.
(Please Detailed Description for termination reason.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00809536
First received: December 15, 2008
Last updated: February 16, 2010
Last verified: February 2010

December 15, 2008
February 16, 2010
January 2009
February 2009   (final data collection date for primary outcome measure)
  • Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf) [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: No ]
  • Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast) [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: No ]
  • Metformin and PD 0332334 half-life (t1/2) [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: No ]
  • Metformin and PD 0332334 maximum plasma concentration [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00809536 on ClinicalTrials.gov Archive Site
  • Clinical safety laboratories [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]
  • Incidence, duration and severity of adverse events when study medications administered alone and concurrently [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]
  • Discontinuation due to adverse events when study medications administered alone and concurrently [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]
  • 12-lead ECGs [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Days 1 through 7 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Generalized Anxiety Disorder
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Nonsmokers
  • Male or female adults

Exclusion Criteria:

  • Current or history of significant medical illness
  • Smokers
  • Illicit drug use
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00809536
A5361031
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