NCT01101919

Brief Summary

This study is designed to evaluate the levels of CP-690,550 in the blood of healthy Chinese subjects following both single doses and multiple doses of drug.

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 healthy

Timeline
Completed

Started Oct 2010

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

April 6, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

Same day

First QC Date

April 6, 2010

Last Update Submit

November 11, 2011

Conditions

Healthy

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Single-dose: Cmax, Tmax, t½, AUCinf and AUClast

    1 day

  • Multiple-dose: Cmin, Cmax, Ctrough, Tmax, t½, AUCtau, and Rac

    5 days

Secondary Outcomes (2)

  • Number of adverse events and number of participants with adverse events

    6 days

  • Changes in complete blood count and serum chemistry profile

    6 days

Study Arms (1)

CP-690,550 Dose Group

EXPERIMENTAL
Drug: CP-690,550

Interventions

CP-690,550DRUG

Days 1 and 6 dose of 10 mg once daily Days 2-5 doses of 10 mg twice daily

CP-690,550 Dose Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Chinese Volunteers
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

You may not qualify if:

  • Clinically significant infections within the past 3 months
  • Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus
  • Pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Beijing, 100032, China

Location

Related Publications (1)

  • Krishnaswami S, Wang T, Yuan Y, Alvey CW, Checchio T, Peterson M, Shi H, Riese R. Single- and multiple-dose pharmacokinetics of tofacitinib in healthy Chinese volunteers. Clin Pharmacol Drug Dev. 2015 Sep;4(5):395-9. doi: 10.1002/cpdd.202. Epub 2015 Jul 16.

    PMID: 27137149DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 6, 2010

First Posted

April 12, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

CN(1)