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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00809536

Purpose

To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body
To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body
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 I

MedlinePlus related topics: Anxiety

Drug Information available for: Metformin Metformin hydrochloride

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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

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 ]

Estimated Enrollment:	24
Study Start Date:	January 2009
Estimated Study Completion Date:	February 2009
Estimated 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 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:

Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5361031
Study First Received:	December 15, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00809536
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

metformin, PD 0332334, organic cation transporter, OCT2, pharmacokinetics

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Metformin
Healthy

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009