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

Phase 1, Open-Label Study To Evaluate Single Dose Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Patients With Impaired Renal Function

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: CP-690,550

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Pfizer Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Pfizer Investigational Site
    • New Orleans, Louisiana, United States, 70118
      • Pfizer Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	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 - ∞).	0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Maximum Observed Plasma Concentration (Cmax)		0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)		0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose
Renal Clearance (CL R)	Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.	0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: October 1, 2003
• Primary Completion (Actual): March 1, 2004
• Study Completion (Actual): March 1, 2004

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Estimate): January 7, 2013
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: pharmacokinetics; renal impairment; CP-690; 550
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921006