A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis

NCT00730145

Last updated date
Study Location
Pfizer Investigational Site
Orlando, Florida, 32809, 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 Dialysis, 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

- Patients receiving regular hemodialysis

- Male or female patients 18 to 65 years

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


- Severe heart failure


- Renal transplant or renal allograft


- Illicit drug use (with the exception of prescribed sedatives)

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Renal Dialysis, PharmacokineticsA Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
NCT00730145
  1. Orlando, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
Official Title  ICMJE A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis
Brief Summary
  1. Quantify how much PD-0332334 is removed from the blood with hemodialysis
  2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving regular hemodialysis treatments.
  3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects receiving hemodialysis.
Detailed Description Assess the elimination of PD-0332334 from the blood with hemodialysis
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 Dialysis
  • Pharmacokinetics
Intervention  ICMJE Drug: PD-0332334
A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject
Other Name: imagabalin
Study Arms  ICMJE Experimental: PD-0332334
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2008)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients receiving regular hemodialysis
  • Male or female patients 18 to 65 years

Exclusion Criteria:

  • Severe heart failure
  • Renal transplant or renal allograft
  • Illicit drug use (with the exception of prescribed sedatives)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00730145
Other Study ID Numbers  ICMJE A5361032
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