NCT01499004

Brief Summary

This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_1 healthy

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

November 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

November 23, 2011

Last Update Submit

January 11, 2012

Conditions

Healthy

Keywords

tofacitinibCP-690550relative bioavailabilitymodified releasePhase 1

Outcome Measures

Primary Outcomes (5)

  • AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time

    72 hours post dose

  • AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration

    72 hours post dose

  • Cmax: Maximum plasma concentration of tofacitinib (CP-690,550)

    72 hours post dose

  • Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration

    72 hours post dose

  • t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma

    72 hours post dose

Secondary Outcomes (1)

  • Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation

    24 hours post dose

Study Arms (6)

Treatment A

EXPERIMENTAL

tofacitinib (CP-690,550) modified-release formulation A-Fed

Drug: tofacitinib (CP-690,550) modified-release formulation A

Treatment B

EXPERIMENTAL

tofacitinib (CP-690,550) modified-release formulation B1-Fed

Drug: tofacitinib (CP-690,550) modified-release formulation B1

Treatment C

EXPERIMENTAL

tofacitinib (CP-690,550) modified-release formulation A-Fasted

Drug: tofacitinib (CP-690,550) modified-release formulation A

Treatment D

EXPERIMENTAL

tofacitinib (CP-690,550) modified-release formulation B1-Fasted

Drug: tofacitinib (CP-690,550) modified-release formulation B1

Treatment E

EXPERIMENTAL

tofacitinib (CP-690,550) modified-release formulation B2-Fasted

Drug: tofacitinib (CP-690,550) modified-release formulation B2

Treatment F

EXPERIMENTAL

tofacitinib (CP-690,550) immediate-release formulation-Fasted

Drug: tofacitinib (CP-690,550) immediate-release formulation

Interventions

tofacitinib (CP-690,550) modified-release formulation ADRUG

A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.

Treatment A
tofacitinib (CP-690,550) modified-release formulation B1DRUG

A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food

Treatment B
tofacitinib (CP-690,550) modified-release formulation B2DRUG

A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food

Treatment E
tofacitinib (CP-690,550) immediate-release formulationDRUG

A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food

Treatment F

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects and/or healthy females subjects who are of non-childbearing potential.

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2011

First Posted

December 26, 2011

Study Start

November 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

SG(1)