A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)

October 12, 2010 updated by: Pfizer

Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions

In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a pivotal bioequivalence study for tasocitinib (CP-690,550).

Study Type

Interventional

Enrollment (Anticipated)

24

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males>50 kg (110 lbs). For females, total body weight >45 kg (99 lbs).
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

Exclusion Criteria:

  • Evidence of any clinically significant illness, medical condition, or disease.
  • Evidence or history of any clinically significant infections within the past 3 months.
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Drug: Treatment A
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Drug: Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Drug: Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Experimental: Sequence 2
Drug: Treatment A
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Drug: Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Drug: Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Experimental: Sequence 3
Drug: Treatment A
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Drug: Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Drug: Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Experimental: Sequence 4
Drug: Treatment A
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Drug: Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Drug: Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Experimental: Sequence 5
Drug: Treatment A
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Drug: Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Drug: Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
Experimental: Sequence 6
Drug: Treatment A
Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
Drug: Treatment B
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
Drug: Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK parameters: AUCinf, AUClast and Cmax of tasocitinib (CP-690,550).
Time Frame: PK blood samples out to 24 hours post dose in each period
PK blood samples out to 24 hours post dose in each period

Secondary Outcome Measures

Outcome Measure
Time Frame
PK parameters: Tmax, t½ of tasocitinib (CP-690,550).
Time Frame: Derived from PK blood samples out to 24 hours post dose in each period.
Derived from PK blood samples out to 24 hours post dose in each period.
Safety: laboratory tests.
Time Frame: Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in Period 3.
Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in Period 3.
Safety: vital signs
Time Frame: Prior to dosing in each period and at 24 hours post last dose in Period 3.
Prior to dosing in each period and at 24 hours post last dose in Period 3.
Safety: adverse event reporting
Time Frame: Throughout study.
Throughout study.

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

August 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 16, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Estimate)

October 14, 2010

Last Update Submitted That Met QC Criteria

October 12, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921075

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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