Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease

Pfizer12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

End-Stage Renal Disease Hemodialysis

Interventions

CP-690,550DRUG

CP-690,550 10 mg oral powder for constitution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

Pfizer Investigational Site

Orlando, Florida, United States

Pfizer Investigational Site

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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 - ∞).

Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)