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Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function

Primary Purpose

Renal Impairment

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 Renal Impairment focused on measuring CP-690, 550, pharmacokinetics, renal impairment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects with normal renal function: Subjects must be healthy with estimated creatinine clearance >80 mL/min
Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease

Exclusion Criteria:

Kidney transplant patients
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
Pfizer Investigational Site
Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Arm Label

Healthy volunteers

Mild renal impairment

Moderate renal impairment

severe renal impairment

Arm Description

Healthy volunteers

patients with mild (>50 and ≤80 mL/min) renal impairment

patients with moderate (≥30 and ≤50 mL/min) renal impairment

patients with severe (<30 mL/min) renal impairment

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 - ∞).

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.

Renal Clearance (CL R)

Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.

Secondary Outcome Measures

Full Information

NCT ID

NCT01740362

First Posted

October 16, 2012

Last Updated

December 3, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01740362

Brief Title

Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function

Official Title

Phase 1, Open-Label Study To Evaluate Single Dose Pharmacokinetics, Safety And Tolerability Of CP-690,550 In Patients With Impaired Renal Function

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

March 2004 (Actual)

Study Completion Date

March 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.

6. Conditions and Keywords

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

Renal Impairment

Keywords

CP-690, 550, pharmacokinetics, renal impairment

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy volunteers

Arm Type

Other

Arm Description

Healthy volunteers

Arm Title

Mild renal impairment

Arm Type

Experimental

Arm Description

patients with mild (>50 and ≤80 mL/min) renal impairment

Arm Title

Moderate renal impairment

Arm Type

Experimental

Arm Description

patients with moderate (≥30 and ≤50 mL/min) renal impairment

Arm Title

severe renal impairment

Arm Type

Experimental

Arm Description

patients with severe (<30 mL/min) renal impairment

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

10 mg (2 x 5 mg tablets), single dose

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

10 mg (2 x 5 mg tablets), single dose

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

10 mg (2 x 5 mg tablets), single dose

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Intervention Description

10 mg (2 x 5 mg tablets), single dose

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), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose

Title

Maximum Observed Plasma Concentration (Cmax)

Time Frame

0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time Frame

0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose

Title

Plasma Decay Half-Life (t1/2)

Description

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

Time Frame

0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose

Title

Renal Clearance (CL R)

Description

Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.

Time Frame

0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with normal renal function: Subjects must be healthy with estimated creatinine clearance >80 mL/min Subjects with renal impairment: Subjects should be in good general health commensurate with the population with chronic kidney disease Exclusion Criteria: Kidney transplant patients Subjects with any condition possibly affecting drug absorption Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Pfizer Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70118

Country

United States

Facility Name

Pfizer Investigational Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

Facility Name

Pfizer Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24030917

Citation

Krishnaswami S, Chow V, Boy M, Wang C, Chan G. Pharmacokinetics of tofacitinib, a janus kinase inhibitor, in patients with impaired renal function and end-stage renal disease. J Clin Pharmacol. 2014 Jan;54(1):46-52. doi: 10.1002/jcph.178. Epub 2013 Sep 30.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921006&StudyName=Pharmacokinetics%20Of%20CP-690%2C550%20In%20Patients%20With%20Impaired%20Renal%20Function%20

Description

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Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function

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