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

Sponsor:	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

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:

MedlinePlus related topics: Anxiety

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

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:

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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 February 09, 2012