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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710020
• Other study ID #: A3921004
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2012
• Last updated: November 19, 2012
• Start date: February 2003
• Est. completion date: June 2003

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• CP-690,550
CP-690,550 10 mg oral powder for constitution

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Dialyser Clearance (CL HD)	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).	0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2	No
Other	Dialyser Clearance (CL HD) From 3 to 3.5 Hour	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).	3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2	No
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).	0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1	No
Primary	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)	0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1	No
Primary	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	No
Primary	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	No
Primary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1	No
Primary	Oral Clearance (CLpo)	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.	0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1	No
Primary	Dialyser Clearance (CL HD) From 0 to 1 Hour	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).	0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2	No
Primary	Dialyser Clearance (CL HD) From 1 to 2 Hour	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).	1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2	No
Primary	Dialyser Clearance (CL HD) From 2 to 3 Hour	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).	2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2	No
Primary	Dialyser Clearance (CL HD) From 3 to 4 Hour	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).	3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2	No
Secondary	Fraction of Unbound Drug (fu)	Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.	2 hours post-dose in Period 1	No

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