A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.

February 16, 2010 updated by: Pfizer

A Phase 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function

  1. To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.
  2. To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.

On February 23rd 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)

16

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
    • California
      • Cypress, California, United States, 90630
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33169
        • 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy volunteers OR subjects with kidney impairment

Exclusion Criteria:

  1. Receiving hemodialysis
  2. clinically significant or unstable medical disease other than kidney disease

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1-Normal
Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
Other Names:
  • imagabalin
Experimental: Group 2-Mild
Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
Other Names:
  • imagabalin
Experimental: Group 3-Moderate
Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
Other Names:
  • imagabalin
Experimental: Group 4-Severe
Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
Other Names:
  • imagabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)
Time Frame: 1 day
1 day
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)
Time Frame: 5 days
5 days
PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast),
Time Frame: 5 to 17 days depending on cohort
5 to 17 days depending on cohort
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),
Time Frame: 5 to 17 days depending on cohort
5 to 17 days depending on cohort

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs
Time Frame: 5 to 17 days
5 to 17 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

August 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

July 22, 2008

First Submitted That Met QC Criteria

July 23, 2008

First Posted (Estimate)

July 24, 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

  • A5361023

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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