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

Phase 1, Open-Label Study Of The Pharmacokinetics, Non-Renal Clearance And Dialyzability Of CP-690,550 In Subjects With End-Stage Renal Disease Undergoing Hemodialysis

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.

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.