Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
- Registration Number
- NCT01710020
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Subjects with end-stage renal disease
- Subjects need hemodialysis 3 times weekly
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CP-690,550 CP-690,550 -
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1 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 - ∞).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1 Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Maximum Observed Plasma Concentration (Cmax) 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1 Time to Reach Maximum Observed Plasma Concentration (Tmax) 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1 Plasma Decay Half-Life (t1/2) 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1 Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Oral Clearance (CLpo) 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1 Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.
Dialyser Clearance (CL HD) From 0 to 1 Hour 0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2 Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\*Cmid\*tm).
Dialyser Clearance (CL HD) From 1 to 2 Hour 1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2 Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\*Cmid\*tm).
Dialyser Clearance (CL HD) From 2 to 3 Hour 2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2 Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\*Cmid\*tm).
Dialyser Clearance (CL HD) From 3 to 4 Hour 3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2 Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu\*Cmid\*tm).
- Secondary Outcome Measures
Name Time Method Fraction of Unbound Drug (fu) 2 hours post-dose in Period 1 Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Minneapolis, Minnesota, United States