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

November 14, 2012
December 20, 2012
November 2012
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01731327 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: tofacitinib modified-release (MR) formulation
    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 22 mg tofacitinib modified-release (MR) administered in a fasting state.
  • Experimental: Experimental Treatment A
    A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
    Intervention: Drug: tofacitinib modified-release (MR) formulation
  • Experimental: Experimental Treatment B
    A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
    Intervention: Drug: tofacitinib modified-release (MR) formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01731327
A3921132
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP