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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740362
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: CP-690,550 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase 1, Open-Label Study To Evaluate Single Dose Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Patients With Impaired Renal Function
Study Start Date : October 2003
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Healthy volunteers
Healthy volunteers
Drug: CP-690,550
10 mg (2 x 5 mg tablets), single dose

Experimental: Mild renal impairment
patients with mild (>50 and ≤80 mL/min) renal impairment
Drug: CP-690,550
10 mg (2 x 5 mg tablets), single dose

Experimental: Moderate renal impairment
patients with moderate (≥30 and ≤50 mL/min) renal impairment
Drug: CP-690,550
10 mg (2 x 5 mg tablets), single dose

Experimental: severe renal impairment
patients with severe (<30 mL/min) renal impairment
Drug: CP-690,550
10 mg (2 x 5 mg tablets), single dose




Primary Outcome Measures :
  1. 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, 12, 16, 24, 48 hours post-dose ]
    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 - ∞).

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose ]
  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose ]
  4. Plasma Decay Half-Life (t1/2) [ Time Frame: 0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  5. Renal Clearance (CL R) [ Time Frame: 0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose ]
    Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740362


Locations
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United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32806
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70118
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70119
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01740362    
Other Study ID Numbers: A3921006
First Posted: December 4, 2012    Key Record Dates
Results First Posted: January 7, 2013
Last Update Posted: January 7, 2013
Last Verified: December 2012
Keywords provided by Pfizer:
CP-690
550
pharmacokinetics
renal impairment
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action