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.

NCT00721422

Last updated date
Study Location
Pfizer Investigational Site
Cypress, California, 90630, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Insufficiency, Pharmacokinetics
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Healthy volunteers OR subjects with kidney impairment

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Receiving hemodialysis


2. clinically significant or unstable medical disease other than kidney disease

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Renal Insufficiency, PharmacokineticsA 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.
NCT00721422
  1. Cypress, California
  2. Miami, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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
Brief Summary
  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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Renal Insufficiency
  • Pharmacokinetics
Intervention  ICMJE
  • Drug: PD 0332334
    50 mg (two 25 mg capsules), single, oral dose
    Other Name: imagabalin
  • Drug: PD 0332334
    50 mg (two 25 mg capsules), single, oral dose
Study Arms  ICMJE
  • Experimental: Group 1-Normal
    Intervention: Drug: PD 0332334
  • Experimental: Group 2-Mild
    Intervention: Drug: PD 0332334
  • Experimental: Group 3-Moderate
    Intervention: Drug: PD 0332334
  • Experimental: Group 4-Severe
    Intervention: Drug: PD 0332334
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 3, 2009)
16
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2008)
32
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00721422
Other Study ID Numbers  ICMJE A5361023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP