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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)

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ClinicalTrials.gov Identifier: NCT01184092
Recruitment Status : Completed
First Posted : August 18, 2010
Last Update Posted : October 14, 2010
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Treatment A Drug: Treatment B Drug: Treatment C Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : August 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010


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 C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).

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).

Experimental: Sequence 3 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).

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).

Experimental: Sequence 4 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 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 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 C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).

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).

Experimental: Sequence 6 Drug: Treatment C
Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).

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 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).




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]
  2. Safety: laboratory tests. [ Time Frame: Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in Period 3. ]
  3. Safety: vital signs [ Time Frame: Prior to dosing in each period and at 24 hours post last dose in Period 3. ]
  4. Safety: adverse event reporting [ Time Frame: Throughout study. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184092


Locations
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Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01184092    
Other Study ID Numbers: A3921075
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: October 14, 2010
Last Verified: October 2010
Keywords provided by Pfizer:
Bioequivalence
healthy volunteer study
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases