Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function

NCT01740362

Last updated date
Study Location
Pfizer Investigational Site
Orlando, Florida, 32806, 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 Impairment
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 normal renal function: Subjects must be healthy with estimated creatinine clearance >80 mL/min

- Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease

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


- Kidney transplant patients


- Subjects with any condition possibly affecting drug absorption


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
Official Title  ICMJE Phase 1, Open-Label Study To Evaluate Single Dose Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Patients With Impaired Renal Function
Brief Summary A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Renal Impairment
Intervention  ICMJE Drug: CP-690,550
10 mg (2 x 5 mg tablets), single dose
Study Arms  ICMJE
  • Healthy volunteers
    Healthy volunteers
    Intervention: Drug: CP-690,550
  • Experimental: Mild renal impairment
    patients with mild (>50 and ?80 mL/min) renal impairment
    Intervention: Drug: CP-690,550
  • Experimental: Moderate renal impairment
    patients with moderate (?30 and ?50 mL/min) renal impairment
    Intervention: Drug: CP-690,550
  • Experimental: severe renal impairment
    patients with severe (<30 mL/min) renal impairment
    Intervention: Drug: CP-690,550
Publications * Krishnaswami S, Chow V, Boy M, Wang C, Chan G. Pharmacokinetics of tofacitinib, a janus kinase inhibitor, in patients with impaired renal function and end-stage renal disease. J Clin Pharmacol. 2014 Jan;54(1):46-52. doi: 10.1002/jcph.178. Epub 2013 Sep 30.

*   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: November 29, 2012)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2004
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with normal renal function: Subjects must be healthy with estimated creatinine clearance >80 mL/min
  • Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease

Exclusion Criteria:

  • Kidney transplant patients
  • Subjects with any condition possibly affecting drug absorption
  • Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin
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 NCT01740362
Other Study ID Numbers  ICMJE A3921006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2012

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