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

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: CP-690,550
* Drug: CP-690,550
* Drug: CP-690,550
* Drug: CP-690,550


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy volunteers<br>Healthy volunteers | Drug: CP-690,550<br>* 10 mg (2 x 5 mg tablets), single dose<br>|
| Experimental: Mild renal impairment<br>patients with mild (>50 and ≤80 mL/min) renal impairment | Drug: CP-690,550<br>* 10 mg (2 x 5 mg tablets), single dose<br>|
| Experimental: Moderate renal impairment<br>patients with moderate (≥30 and ≤50 mL/min) renal impairment | Drug: CP-690,550<br>* 10 mg (2 x 5 mg tablets), single dose<br>|
| Experimental: severe renal impairment<br>patients with severe (<30 mL/min) renal impairment | Drug: CP-690,550<br>* 10 mg (2 x 5 mg tablets), single dose<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CP-690, 550, pharmacokinetics, renal impairment