A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers

A Phase 1, Randomized, Open Label, Single Dose, 2-Period Crossover Study To Evaluate The Effect Of Food On The Pharmacokinetics Of Tofacitinib Modified Release (MR) 11 Mg Tablets In Healthy Western And Japanese Volunteers

This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: tofacitinib modified-release (MR) formulation; Drug: tofacitinib modified-release (MR) formulation

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Glendale Adventist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male volunteers and/or healthy females volunteers of non-childbearing potential who are 18 to 55 years of age;
• Healthy volunteers who are of Japanese or Western descent;
• Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tofacitinib MR 11 mg Fed; tofacitinib modified release (MR) 11 mg tablet administered with food.	Drug: tofacitinib modified-release (MR) formulation; A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.; Drug: tofacitinib modified-release (MR) formulation; tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.
Experimental: tofacitinib MR 11 mg Fasting; tofacitinib modified release (MR) 11 mg tablet administered without food.	Drug: tofacitinib modified-release (MR) formulation; A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.; Drug: tofacitinib modified-release (MR) formulation; tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve from time zero to infinity	Area under the curve from time zero to infinity	48 hours post dose
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration	Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration	48 hours post dose
Maximum Observed Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration (Cmax)	48 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Time to peak concentration	48 hours post dose
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	48 hours post dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2014
• Primary Completion (Actual): May 25, 2014
• Study Completion (Actual): May 25, 2014

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: healthy volunteer; Food effect; pharmacokinetic
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921180