A Study To Compare The Amount Of CP-690,550 That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Two Different Strength Tablets Of CP-690,550

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01277991
First received: January 13, 2011
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet .


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2-period, Crossover, Bioequivalence Study Comparing Phase 2b 1 Mg And 5 Mg Tablet Formulations Of Cp-690,550 Under Fasted Conditions

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • PK parameters: AUCinf, AUClast and Cmax of CP-690,550 [ Time Frame: PK blood samples out to 24 hours post dose in each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK parameters: Tmax, AUCt and half-life of CP-690,550 [ Time Frame: Derived from PK blood samples out to 24 hours post dose in each period ] [ Designated as safety issue: No ]
  • Safety: laboratory tests [ Time Frame: Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period ] [ Designated as safety issue: Yes ]
  • Safety: vital signs [ Time Frame: Prior to dosing in each period and at 24 hours post last dose in Period 2 ] [ Designated as safety issue: Yes ]
  • Safety: adverse event reporting [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 Drug: Treatment A
Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)
Drug: Treatment B
Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
Experimental: Sequence 2 Drug: Treatment B
Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
Drug: Treatment A
Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)

Detailed Description:

This is a bioequivalence study for CP-690,550.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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 >45 kg (99 lbs).
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

Exclusion Criteria:

Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Personal or family history of hereditary immunodeficiency (eg, severe - 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277991

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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01277991     History of Changes
Other Study ID Numbers: A3921135
Study First Received: January 13, 2011
Last Updated: April 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bioequivalence
healthy volunteer study
Rheumatoid Arthritis

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

ClinicalTrials.gov processed this record on October 23, 2014