NCT00969813

Brief Summary

This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 11, 2010

Status Verified

February 1, 2010

Enrollment Period

2 months

First QC Date

August 31, 2009

Last Update Submit

February 10, 2010

Conditions

Hepatic Insufficiency

Keywords

Hepatic impairment

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function

    3 days

Secondary Outcomes (1)

  • Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function

    10-14 days

Study Arms (3)

Normal hepatic function

EXPERIMENTAL
Drug: CP-690,550

Mild hepatic impairment

EXPERIMENTAL
Drug: CP-690,550

Moderate hepatic impairment

EXPERIMENTAL
Drug: CP-690,550

Interventions

CP-690,550DRUG

Single 10 mg dose of CP-690,550

Normal hepatic function

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers who have normal liver function, and subjects who have either mild or moderate liver impairment.

You may not qualify if:

  • Subjects with severe liver impairment
  • Subjects who have weakened immune systems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Related Publications (1)

  • Lawendy N, Lamba M, Chan G, Wang R, Alvey CW, Krishnaswami S. The effect of mild and moderate hepatic impairment on the pharmacokinetics of tofacitinib, an orally active Janus kinase inhibitor. Clin Pharmacol Drug Dev. 2014 Nov;3(6):421-7. doi: 10.1002/cpdd.143. Epub 2014 Oct 1.

    PMID: 27129117DERIVED

Related Links

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 11, 2010

Record last verified: 2010-02

Locations

US(1)