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

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NCT00730145

Last updated on May 11, 2018
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Study Location
Pfizer Investigational Site
Orlando, Florida, 32809 United States
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Contact
1-800-718-1021
[email protected]
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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)

NCT00730145
Pfizer
Completed
A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis

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[email protected]

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A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis
  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.
Assess the elimination of PD-0332334 from the blood with hemodialysis
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
  • Renal Dialysis
  • Pharmacokinetics
Drug: PD-0332334
A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject
Other Name: imagabalin
Experimental: PD-0332334
Intervention: Drug: PD-0332334
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
January 2009
January 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00730145
A5361032
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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