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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CP-690,550

About this trial

This is an interventional basic science trial for End-Stage Renal Disease focused on measuring CP-690, 550, pharmacokinetics, end-stage renal disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CP-690,550

Arm Description

Outcomes

Primary Outcome Measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

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)

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Maximum Observed Plasma Concentration (Cmax)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Plasma Decay Half-Life (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

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.

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).

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).

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).

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).

Secondary Outcome Measures

Fraction of Unbound Drug (fu)

Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.

Full Information

NCT ID

NCT01710020

First Posted

October 16, 2012

Last Updated

November 19, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01710020

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

February 2003 (undefined)

Primary Completion Date

June 2003 (Actual)

Study Completion Date

June 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End-Stage Renal Disease, Hemodialysis

Keywords

CP-690, 550, pharmacokinetics, end-stage renal disease

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CP-690,550

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

CP-690,550 10 mg oral powder for constitution

Primary Outcome Measure Information:

Title

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

Description

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 - ∞).

Time Frame

0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1

Title

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Description

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Time Frame