A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers

December 20, 2012 updated by: Pfizer

A Phase 1, Randomized, Open-Label, 2-Way Crossover Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of Tofacitinib Following Single Oral Dose Of MR 11 mg Compared To MR 22 mg In Healthy Volunteers

This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male subjects and/or healthy female 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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Treatment A
A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
Drug: tofacitinib modified-release (MR) formulation
A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
Drug: tofacitinib modified-release (MR) formulation
A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
Experimental: Experimental Treatment B
A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
Drug: tofacitinib modified-release (MR) formulation
A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
Drug: tofacitinib modified-release (MR) formulation
A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized
Time Frame: 72 hours post dose
72 hours post dose
Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized
Time Frame: 72 hours post dose
72 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized
Time Frame: 72 hours post dose
72 hours post dose
AUCinf: Area Under the Curve From Time Zero to Infinity
Time Frame: 72 hours post dose
72 hours post dose
Cmax: Maximum Observed Plasma Concentration
Time Frame: 72 hours post dose
72 hours post dose
AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration
Time Frame: 72 hours post dose
72 hours post dose
Tmax: Amount of time drug takes to reach Cmax
Time Frame: 72 hours post dose
72 hours post dose
t ½: Terminal elimination half-life
Time Frame: 72 hours post dose
72 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

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, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 16, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

December 24, 2012

Last Update Submitted That Met QC Criteria

December 20, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921132

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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