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

Pfizer

Status and phase: Completed; Phase 1

Conditions: End-Stage Renal Disease; Hemodialysis

Treatments: Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT01710020

A3921004

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

CP-690,550

Experimental group

Treatment:

Drug: CP-690,550