CP-690,550 Pharmacokinetics In Healthy Chinese Subjects | NCT01101919

Studies
CP-690,550 Pharmacokinetics In Healthy Chinese Subjects

NCT01101919

Sponsor

Pfizer

Status

Completed

Last Update Posted

Nov 16, 2011Estimated

Enrollment

12Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

CP-690,550

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Apr 6, 2010

First Submission Date that Met QC Criteria

Apr 8, 2010

First Posted Date

Apr 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2011

Last Update Posted Date

Nov 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CP-690,550 Dose Group	Experimental		Drug: CP-690,550

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CP-690,550	Drug	Days 1 and 6 dose of 10 mg once daily Days 2-5 doses of 10 mg twice daily	CP-690,550 Dose Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Single-dose: Cmax, Tmax, t½, AUCinf and AUClast		1 day
Multiple-dose: Cmin, Cmax, Ctrough, Tmax, t½, AUCtau, and Rac		5 days

Secondary Outcomes

Measure	Description	Time Frame
Number of adverse events and number of participants with adverse events		6 days
Changes in complete blood count and serum chemistry profile		6 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Beijing		100032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27137149	Derived	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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases