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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)

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01184092
Pfizer
Completed
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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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)
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.
This is a pivotal bioequivalence study for tasocitinib (CP-690,550).
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Rheumatoid Arthritis
  • 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 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2010
September 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
 
NCT01184092
A3921075
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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