NCT01740362

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_1

Geographic Reach
1 country

4 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

October 1, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
1 month until next milestone

Results Posted

Study results publicly available

January 7, 2013

Completed
Last Updated

January 7, 2013

Status Verified

December 1, 2012

Enrollment Period

5 months

First QC Date

October 16, 2012

Results QC Date

December 3, 2012

Last Update Submit

December 3, 2012

Conditions

Renal Impairment

Keywords

CP-690550pharmacokineticsrenal impairment

Outcome Measures

Primary Outcomes (5)

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

  • Maximum Observed Plasma Concentration (Cmax)

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

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

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

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

  • 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.

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

Study Arms (4)

Healthy volunteers

OTHER

Healthy volunteers

Drug: CP-690,550

Mild renal impairment

EXPERIMENTAL

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

Drug: CP-690,550

Moderate renal impairment

EXPERIMENTAL

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

Drug: CP-690,550

severe renal impairment

EXPERIMENTAL

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

Drug: CP-690,550

Interventions

CP-690,550DRUG

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

Healthy volunteers

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Orlando, Florida, 32806, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70118, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70119, 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

Renal Insufficiency

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2012

First Posted

December 4, 2012

Study Start

October 1, 2003

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

January 7, 2013

Results First Posted

January 7, 2013

Record last verified: 2012-12

Locations

US(4)