Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01184092
Previous Study | Return to List | Next Study

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01184092
Recruitment Status : Completed
First Posted : August 18, 2010
Last Update Posted : October 14, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 16, 2010
First Posted Date  ICMJE August 18, 2010
Last Update Posted Date October 14, 2010
Study Start Date  ICMJE August 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01184092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2010)
  • 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. ]
  • Safety: laboratory tests. [ Time Frame: 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. ]
  • Safety: adverse event reporting [ Time Frame: Throughout study. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description This is a pivotal bioequivalence study for tasocitinib (CP-690,550).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • Experimental: Sequence 1
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment B
    • Drug: Treatment C
  • Experimental: Sequence 2
    Interventions:
    • Drug: Treatment A
    • Drug: Treatment C
    • Drug: Treatment B
  • Experimental: Sequence 3
    Interventions:
    • Drug: Treatment B
    • Drug: Treatment C
    • Drug: Treatment A
  • Experimental: Sequence 4
    Interventions:
    • Drug: Treatment B
    • Drug: Treatment A
    • Drug: Treatment C
  • Experimental: Sequence 5
    Interventions:
    • Drug: Treatment C
    • Drug: Treatment A
    • Drug: Treatment B
  • Experimental: Sequence 6
    Interventions:
    • Drug: Treatment C
    • Drug: Treatment B
    • Drug: Treatment A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 16, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01184092
Other Study ID Numbers  ICMJE A3921075
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP