A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers

August 17, 2015 updated by: Pfizer

A Phase 1, Randomized, Open Label, Single Dose, 2 Period Crossover Study To Evaluate The Effect Of Food On The Pharmacokinetics Of Tofacitinib Modified Release (mr) 22 Mg Tablets In Healthy Volunteers

This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Clinical Research Unit

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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male volunteers and/or healthy female volunteers of non-childbearing potential who are 18 to 55 years of age;
  • Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tofacitinib MR 22 mg Fed
Single dose of tofacitinib MR 22 mg administered under fed conditions
Drug: Tofacitinib MR 22 mg (Fed)
A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal
Experimental: Tofacitinib MR 22 mg Fasted
Single dose of tofacitinib MR 22 mg administered under fasted conditions
Drug: Tofacitinib MR 22 mg (Fasted)
A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC inf
Time Frame: 48 hours post dose
Area under the plasma concentration-time profile from time zero to infinity (AUCinf).
48 hours post dose
AUC last
Time Frame: 48 hours post dose
Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).
48 hours post dose
Cmax
Time Frame: 48 hours post dose
Maximum observed plasma concentration (Cmax).
48 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 48 hours post dose
48 hours post dose
Plasma Decay Half-Life (t 1/2)
Time Frame: 48 hours post dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
48 hours post dose

Collaborators and Investigators

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

Sponsor

Pfizer

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

June 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921217
  • 2014-005056-26 (EudraCT Number)

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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