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

Phase 1

Completed

• Conditions: Hemodialysis; End-Stage Renal Disease
• Interventions: Drug: CP-690,550

• 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

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Status Verified: 2012-11
• Results First Submitted: 2012-11-19
• Results First Submitted QC: 2012-11-19
• Last Update Submitted: 2012-11-19
• Results First Posted: 2012-12-18
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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