A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01731327
First received: November 14, 2012
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.


Condition Intervention Phase
Healthy
Drug: tofacitinib modified-release (MR) 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, 2-Way Crossover Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of Tofacitinib Following Single Oral Dose Of MR 11 mg Compared To MR 22 mg In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUCinf(dn): Area Under the Curve From Time Zero to Infinity, dose-normalized [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • Cmax(dn): Maximum Observed Plasma Concentration (Cmax), dose normalized [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUClast(dn): Area Under the Curve From Time Zero to Last Quantifiable Concentration, dose normalized [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • AUCinf: Area Under the Curve From Time Zero to Infinity [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • Cmax: Maximum Observed Plasma Concentration [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • AUClast: Area Under the Curve From Time Zero to Last Quantifiable Concentration [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • Tmax: Amount of time drug takes to reach Cmax [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]
  • t ½: Terminal elimination half-life [ Time Frame: 72 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Treatment A
A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
Drug: tofacitinib modified-release (MR) formulation
A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
Experimental: Experimental Treatment B
A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
Drug: tofacitinib modified-release (MR) formulation
A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.

  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 female 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: NCT01731327

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: NCT01731327     History of Changes
Other Study ID Numbers: A3921132
Study First Received: November 14, 2012
Last Updated: December 20, 2012
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on July 09, 2014