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A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01499004
First Posted: December 26, 2011
Last Update Posted: January 12, 2012
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 (Responsible Party):
Pfizer
  Purpose
This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.

Condition Intervention Phase
Healthy Drug: tofacitinib (CP-690,550) modified-release formulation A Drug: tofacitinib (CP-690,550) modified-release formulation B1 Drug: tofacitinib (CP-690,550) modified-release formulation B2 Drug: tofacitinib (CP-690,550) immediate-release formulation Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomized, Open Label, Partial Crossover Study To Evaluate The Pharmacokinetics (PK) And Safety Of Three Modified Release (MR) And One Immediate Release (IR) Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf: Area under the plasma concentration-time profile from time 0 exprapolated to infinite time [ Time Frame: 72 hours post dose ]
  • AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration [ Time Frame: 72 hours post dose ]
  • Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) [ Time Frame: 72 hours post dose ]
  • Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration [ Time Frame: 72 hours post dose ]
  • t1/2: The time required for one half of the total amount of tofacitinib (CP-690,550) to be removed from the plasma [ Time Frame: 72 hours post dose ]

Secondary Outcome Measures:
  • Frel: Relative bioavailability (Frel) of tofacitinib (CP-690,550) in the modified-release formulations compared to the immediate release formulation [ Time Frame: 24 hours post dose ]

Enrollment: 30
Study Start Date: November 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
tofacitinib (CP-690,550) modified-release formulation A-Fed
Drug: tofacitinib (CP-690,550) modified-release formulation A
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.
Experimental: Treatment B
tofacitinib (CP-690,550) modified-release formulation B1-Fed
Drug: tofacitinib (CP-690,550) modified-release formulation B1
A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food
Experimental: Treatment C
tofacitinib (CP-690,550) modified-release formulation A-Fasted
Drug: tofacitinib (CP-690,550) modified-release formulation A
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food
Experimental: Treatment D
tofacitinib (CP-690,550) modified-release formulation B1-Fasted
Drug: tofacitinib (CP-690,550) modified-release formulation B1
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food
Experimental: Treatment E
tofacitinib (CP-690,550) modified-release formulation B2-Fasted
Drug: tofacitinib (CP-690,550) modified-release formulation B2
A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food
Experimental: Treatment F
tofacitinib (CP-690,550) immediate-release formulation-Fasted
Drug: tofacitinib (CP-690,550) immediate-release formulation
A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food

  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 subjects and/or healthy females subjects who are of non-childbearing potential.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
  • Clinically significant infections within the past 3 months
  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): NCT01499004


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: Pfizer
ClinicalTrials.gov Identifier: NCT01499004     History of Changes
Other Study ID Numbers: A3921131
First Submitted: November 23, 2011
First Posted: December 26, 2011
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by Pfizer:
tofacitinib
CP-690
550
relative bioavailability
modified release
Phase 1

Additional relevant MeSH terms:
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action