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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: CP-690,550

• Registration Number: NCT01740362
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-11-29
• Status Verified: 2012-12
• Results First Submitted: 2012-12-03
• Results First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Study First Posted: 2012-12-04
• Results First Posted: 2013-01-07
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate renal impairment	CP-690,550	patients with moderate (≥30 and ≤50 mL/min) renal impairment
severe renal impairment	CP-690,550	patients with severe (\<30 mL/min) renal impairment
Healthy volunteers	CP-690,550	Healthy volunteers
Mild renal impairment	CP-690,550	patients with mild (\>50 and ≤80 mL/min) renal impairment

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	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 - ∞).
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)	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.
Renal Clearance (CL R)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Minneapolis, Minnesota, United States