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
  Purpose
  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.

Condition Intervention Phase
Generalized Anxiety Disorder
Drug: Metformin
Drug: PD 0332334
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cohort 1
This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
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
Cohort 2
This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nonsmokers
  • Male or female adults

Exclusion Criteria:

  • Current or history of significant medical illness
  • Smokers
  • Illicit drug use
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809536

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00809536     History of Changes
Other Study ID Numbers: A5361031
Study First Received: December 15, 2008
Last Updated: February 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
metformin, PD 0332334, organic cation transporter, OCT2, pharmacokinetics

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014