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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02084875
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.4
• Patients Per Site Per Month: 16.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: tofacitinib modified-release (MR) formulation; Drug: tofacitinib modified-release (MR) formulation	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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
• Actual Study Start Date: Apr 11, 2014
• Actual Primary Completion Date: May 25, 2014
• Actual Study Completion Date: May 25, 2014

Arms and Interventions

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.
Experimental: tofacitinib MR 11 mg Fasting tofacitinib modified release (MR) 11 mg tablet administered without food.	Drug: tofacitinib modified-release (MR) formulation; tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.

Outcome Measures

Primary Outcome Measures

1. Area under the curve from time zero to infinity [48 hours post dose]

   Area under the curve from time zero to infinity

2. Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration [48 hours post dose]

   Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration

3. Maximum Observed Plasma Concentration (Cmax) [48 hours post dose]

   Maximum Observed Plasma Concentration (Cmax)

Secondary Outcome Measures

1. Time to Reach Maximum Observed Plasma Concentration (Tmax) [48 hours post dose]

   Time to peak concentration

2. Plasma Decay Half-Life (t1/2) [48 hours post dose]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glendale Adventist Medical Center	Glendale	California	United States	91206

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02084875
• Other Study ID Numbers: A3921180
• First Posted: Mar 12, 2014
• Last Update Posted: Nov 30, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by Pfizer: Food effect; pharmacokinetic; healthy volunteer
• Additional relevant MeSH terms: Tofacitinib

Study Results

No Results Posted as of Nov 30, 2018