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Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Orlando, Florida, 32806 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
End-Stage Renal Disease, Hemodialysis
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

- Subjects with end-stage renal disease

- Subjects need hemodialysis 3 times weekly

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

- Subjects with evidence or history of clinically significant disease, excluding those
common for subjects with End-Stage Renal Disease (ESRD).

- Subjects with any condition possibly affecting drug absorption.

- Subjects with malignancies with the exception of adequately treated basal cell
carcinoma of the skin.

NCT01710020
Pfizer
Completed
Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease

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Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
Phase 1, Open-Label Study Of The Pharmacokinetics, Non-Renal Clearance And Dialyzability Of CP-690,550 In Subjects With End-Stage Renal Disease Undergoing Hemodialysis
There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a second period (Period 2) will be conducted. In Period 2, a single dose of drug will be administered approximately 4 hours prior to hemodialysis.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • End-Stage Renal Disease
  • Hemodialysis
Drug: CP-690,550
CP-690,550 10 mg oral powder for constitution
Experimental: CP-690,550
Intervention: Drug: CP-690,550
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2003
June 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with end-stage renal disease
  • Subjects need hemodialysis 3 times weekly

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant disease, excluding those common for subjects with End-Stage Renal Disease (ESRD).
  • Subjects with any condition possibly affecting drug absorption.
  • Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin.
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
 
 
NCT01710020
A3921004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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