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

February 16, 2010 updated by: Pfizer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 188770
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nonsmokers
  • Male or female adults

Exclusion Criteria:

  • Current or history of significant medical illness
  • Smokers
  • Illicit drug use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • imagabalin
Drug: Metformin
Single, oral, 500 mg of metformin immediate release
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)
Time Frame: Days 1 through 7
Days 1 through 7
Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
Time Frame: Days 1 through 7
Days 1 through 7
Metformin and PD 0332334 half-life (t1/2)
Time Frame: Days 1 through 7
Days 1 through 7
Metformin and PD 0332334 maximum plasma concentration
Time Frame: Days 1 through 7
Days 1 through 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical safety laboratories
Time Frame: Days 1 through 7
Days 1 through 7
Incidence, duration and severity of adverse events when study medications administered alone and concurrently
Time Frame: Days 1 through 7
Days 1 through 7
Discontinuation due to adverse events when study medications administered alone and concurrently
Time Frame: Days 1 through 7
Days 1 through 7
12-lead ECGs
Time Frame: Days 1 through 7
Days 1 through 7
Vital signs
Time Frame: Days 1 through 7
Days 1 through 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (Estimate)

December 17, 2008

Study Record Updates

Last Update Posted (Estimate)

February 17, 2010

Last Update Submitted That Met QC Criteria

February 16, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5361031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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