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
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 April 15, 2014