NCT01185184

Brief Summary

This study will explore the drug behavior and safety following single dose of two 20 milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a 10 milligram immediate release tablet, using a 3 way crossover design.

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 Aug 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

Study Start

First participant enrolled

August 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

Same day

First QC Date

August 18, 2010

Last Update Submit

September 13, 2010

Conditions

Healthy

Keywords

Relative bioavailabilitycontrolled releasePhase 1CP-690550

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters: AUCinf(dn), Frel and Cmax(dn) of CP-690,550

    36 hours

Secondary Outcomes (2)

  • Pharmacokinetic parameters: AUCinf, AUClast, AUClast(dn), Cmax, Tmax, t½, C12h, C24h of CP-690,550

    9 days

  • Safety: laboratory tests, adverse events reporting, ECG and vital signs

    9 days

Study Arms (1)

1

EXPERIMENTAL

Subjects will receive in random order, the immediate release tablet containing 10 mg of CP-690,550 and two different controlled-release capsules containing 20 mg of CP-690,550.

Drug: CP-690,550

Interventions

CP-690,550DRUG

Single doses separated by a minimum of 72 hour washout between treatments

1

Eligibility Criteria

Age21 Months - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy male and/or female subjects

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Clinically significant infections within the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Interventions

tofacitinib

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 19, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

SG(1)