A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

January 11, 2012 updated by: Pfizer

A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Singapore
- - Singapore, Singapore, 188770
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A tofacitinib (CP-690,550) modified-release formulation A-Fed	Drug: tofacitinib (CP-690,550) modified-release formulation A A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food. Drug: tofacitinib (CP-690,550) modified-release formulation A A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food
Experimental: Treatment B tofacitinib (CP-690,550) modified-release formulation B1-Fed	Drug: tofacitinib (CP-690,550) modified-release formulation B1 A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food Drug: tofacitinib (CP-690,550) modified-release formulation B1 A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food
Experimental: Treatment C tofacitinib (CP-690,550) modified-release formulation A-Fasted	Drug: tofacitinib (CP-690,550) modified-release formulation A A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food. Drug: tofacitinib (CP-690,550) modified-release formulation A A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food
Experimental: Treatment D tofacitinib (CP-690,550) modified-release formulation B1-Fasted	Drug: tofacitinib (CP-690,550) modified-release formulation B1 A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food Drug: tofacitinib (CP-690,550) modified-release formulation B1 A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food
Experimental: Treatment E tofacitinib (CP-690,550) modified-release formulation B2-Fasted	Drug: tofacitinib (CP-690,550) modified-release formulation B2 A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food
Experimental: Treatment F tofacitinib (CP-690,550) immediate-release formulation-Fasted	Drug: tofacitinib (CP-690,550) immediate-release formulation A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time Time Frame: 72 hours post dose	72 hours post dose
AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration Time Frame: 72 hours post dose	72 hours post dose
Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) Time Frame: 72 hours post dose	72 hours post dose
Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration Time Frame: 72 hours post dose	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 Time Frame: 72 hours post dose	72 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation Time Frame: 24 hours post dose	24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 23, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

A3921131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on tofacitinib (CP-690,550) modified-release formulation A

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