Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

February 16, 2010 updated by: Pfizer

A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects

The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Detailed Description:

Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334.

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)

12

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

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • 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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy
  • male or female adults

Exclusion Criteria:

  • Current or history of clinically 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
Experimental: Single dose PD 0332334
Drug: PD 0332334
Single 300 mg dose of PD 0332334 immediate release capsules administered orally
Other Names:
  • imagabalin
Drug: PD 0332334
Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.
Experimental: Single dose PD 0332334 with steady-state cimetidine
Drug: PD 0332334
Single 300 mg dose of PD 0332334 immediate release capsules administered orally
Other Names:
  • imagabalin
Drug: PD 0332334
Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.
Drug: cimetidine
600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)
Time Frame: 4 to 6 days
4 to 6 days
PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
Time Frame: 4 to 6 days
4 to 6 days
Half-life (t1/2) of PD 0332334
Time Frame: 4 to 6 days
4 to 6 days
Maximum plasma concentration (Cmax) of PD 0332334
Time Frame: 4 to 6 days
4 to 6 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the incidence, duration and severity of adverse events
Time Frame: 4 to 6 days
4 to 6 days
Evaluate the discontinuation due to adverse events
Time Frame: 4 to 6 days
4 to 6 days
Clinical safety labs
Time Frame: 4 to 6 days
4 to 6 days
ECG
Time Frame: 4 to 6 days
4 to 6 days
Vital signs
Time Frame: 4 to 6 days
4 to 6 days

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 1, 2008

First Submitted That Met QC Criteria

December 1, 2008

First Posted (Estimate)

December 2, 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

  • A5361030

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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