NCT01710020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 18, 2012

Completed
Last Updated

December 18, 2012

Status Verified

November 1, 2012

Enrollment Period

4 months

First QC Date

October 16, 2012

Results QC Date

November 19, 2012

Last Update Submit

November 19, 2012

Conditions

End-Stage Renal DiseaseHemodialysis

Keywords

CP-690550pharmacokineticsend-stage renal disease

Outcome Measures

Primary Outcomes (10)

  • 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 - ∞).

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

  • 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

  • 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)

    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

  • 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

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • Fraction of Unbound Drug (fu)

    2 hours post-dose in Period 1

Other Outcomes (2)

  • Overall Dialyser Clearance (CL HD)

    0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2

  • Dialyser Clearance (CL HD) From 3 to 3.5 Hour

    3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2

Study Arms (1)

CP-690,550

EXPERIMENTAL
Drug: CP-690,550

Interventions

CP-690,550DRUG

CP-690,550 10 mg oral powder for constitution

CP-690,550

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with end-stage renal disease
  • Subjects need hemodialysis 3 times weekly

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Orlando, Florida, 32806, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

  • 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.

    PMID: 24030917DERIVED

Related Links

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2012

First Posted

October 18, 2012

Study Start

February 1, 2003

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

December 18, 2012

Results First Posted

December 18, 2012

Record last verified: 2012-11

Locations

US(2)