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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01499004
First received: November 23, 2011
Last updated: January 11, 2012
Last verified: January 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • AUClast: Area under the plasma concentration-time profile from time 0 to the last with quantifiable concentration [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • Cmax: Maximum plasma concentration of tofacitinib (CP-690,550) [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • Tmax: Amount of time tofacitinib (CP-690,550) is at maximum plasma concentration [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01499004     History of Changes
Other Study ID Numbers: A3921131
Study First Received: November 23, 2011
Last Updated: January 11, 2012
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on July 22, 2014