A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers
- Registration Number
- NCT02084875
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description tofacitinib MR 11 mg Fasting tofacitinib modified-release (MR) formulation tofacitinib modified release (MR) 11 mg tablet administered without food. tofacitinib MR 11 mg Fed tofacitinib modified-release (MR) formulation tofacitinib modified release (MR) 11 mg tablet administered with food.
- Primary Outcome Measures
Name Time Method Area under the curve from time zero to infinity 48 hours post dose Area under the curve from time zero to infinity
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
Maximum Observed Plasma Concentration (Cmax) 48 hours post dose Maximum Observed Plasma Concentration (Cmax)
- Secondary Outcome Measures
Name Time Method Time to Reach Maximum Observed Plasma Concentration (Tmax) 48 hours post dose Time to peak concentration
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.
Trial Locations
- Locations (1)
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States