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Trial record 1 of 1 for:    NCT01710020
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Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease

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ClinicalTrials.gov Identifier: NCT01710020
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : December 18, 2012
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 16, 2012
First Posted Date  ICMJE October 18, 2012
Results First Submitted Date  ICMJE November 19, 2012
Results First Posted Date  ICMJE December 18, 2012
Last Update Posted Date December 18, 2012
Study Start Date  ICMJE February 2003
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1 ]
    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1 ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1 ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Oral Clearance (CLpo) [ Time Frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.
  • Dialyser Clearance (CL HD) From 0 to 1 Hour [ Time Frame: 0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2 ]
    Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
  • Dialyser Clearance (CL HD) From 1 to 2 Hour [ Time Frame: 1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2 ]
    Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
  • Dialyser Clearance (CL HD) From 2 to 3 Hour [ Time Frame: 2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2 ]
    Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
  • Dialyser Clearance (CL HD) From 3 to 4 Hour [ Time Frame: 3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2 ]
    Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2012)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10 hours (hrs) post-dose on Day 1, 18 24 hrs post-dose on Day 2 ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10 hours (hrs) post-dose on Day 1, 18 24 hrs post-dose on Day 2 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10 hours (hrs) post-dose on Day 1, 18 24 hrs post-dose on Day 2 ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10 hours (hrs) post-dose on Day 1, 18 24 hrs post-dose on Day 2 ]
  • Oral Non-renal Clearance (CLpo) [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10 hours (hrs) post-dose on Day 1, 18 24 hrs post-dose on Day 2 ]
  • Dialyser Clearance (CL HD) [ Time Frame: 1-4 hours during dialysis in Period 2 ]
Change History Complete list of historical versions of study NCT01710020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
Fraction of Unbound Drug (fu) [ Time Frame: 2 hours post-dose in Period 1 ]
Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2012)
  • Plasma protein binding of CP-690,550 [ Time Frame: 2 hours post-dose in Period 1 ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10 hours (hrs) post-dose on Day 1, 18 24 hrs post-dose on Day 2 ]
Current Other Pre-specified Outcome Measures
 (submitted: November 19, 2012)
  • Overall Dialyser Clearance (CL HD) [ Time Frame: 0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2 ]
    Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
  • Dialyser Clearance (CL HD) From 3 to 3.5 Hour [ Time Frame: 3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2 ]
    Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • End-Stage Renal Disease
  • Hemodialysis
Intervention  ICMJE Drug: CP-690,550
CP-690,550 10 mg oral powder for constitution
Study Arms  ICMJE Experimental: CP-690,550
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: October 16, 2012)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2003
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT01710020
Other Study ID Numbers  ICMJE A3921004
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 Center Pfizer
PRS Account Pfizer
Verification Date November 2012

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