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A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01184001
First Posted: August 18, 2010
Last Update Posted: October 13, 2010
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.
Information provided by:
Pfizer
  Purpose
In this study, a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy subjects on two separate dosing occasions. On one occasion the tasocitinib (CP-690,550) tablet will be administered in a fasting condition; On the other occasion the tasocitinib (CP-690,550) tablet will be administered in a fed condition following a standard breakfast meal. The amount of tasocitinib (CP-690,550) in the blood will be measured at various times over 24 hours following each dosing occasion and compared to evaluate for any differences.

Condition Intervention Phase
Rheumatoid Arthritis Drug: Treatment A Drug: Treatment B Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf and Cmax of tasocitinib (CP-690,550). [ Time Frame: PK blood samples out to 24 hours post dose in each of two periods. ]

Secondary Outcome Measures:
  • AUClast, Tmax, and t1/2 of tasocitinib (CP-690,550). [ Time Frame: PK blood samples out to 24 hours post dose in each of two periods. ]
  • Safety: Laboratory tests. [ Time Frame: Pre-dose on Day O of Period 1 and post-dose on Day 2 of Period 2. ]
  • Safety:Vital signs. [ Time Frame: Prior to dosing in Period 1 and 2. ]
  • Safety: AE reporting. [ Time Frame: Continuous ]

Enrollment: 16
Study Start Date: September 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 Drug: Treatment A
Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.
Drug: Treatment B
Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.
Experimental: Sequence 2 Drug: Treatment B
Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.
Drug: Treatment A
Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.

Detailed Description:
To evaluate the effect of food on the pharmacokinetics of tasocitinib (CP-690,550).
  Eligibility

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.
  • 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 or history 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.
  Contacts and Locations
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): NCT01184001


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01184001     History of Changes
Other Study ID Numbers: A3921076
First Submitted: August 17, 2010
First Posted: August 18, 2010
Last Update Posted: October 13, 2010
Last Verified: October 2010

Keywords provided by Pfizer:
Healthy subjects
Food Effect Study

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action


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