A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy 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) 22 Mg Tablets In Healthy Volunteers
2 other identifiers
interventional
18
1 country
1
Brief Summary
This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 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 22 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jun 2015
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 19, 2015
August 1, 2015
1 month
April 23, 2015
August 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
AUC inf
Area under the plasma concentration-time profile from time zero to infinity (AUCinf).
48 hours post dose
AUC last
Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).
48 hours post dose
Cmax
Maximum observed plasma concentration (Cmax).
48 hours post dose
Secondary Outcomes (2)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
48 hours post dose
Plasma Decay Half-Life (t 1/2)
48 hours post dose
Study Arms (2)
Tofacitinib MR 22 mg Fed
EXPERIMENTALSingle dose of tofacitinib MR 22 mg administered under fed conditions
Tofacitinib MR 22 mg Fasted
EXPERIMENTALSingle dose of tofacitinib MR 22 mg administered under fasted conditions
Interventions
A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal
A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours
Eligibility Criteria
You may qualify if:
- Healthy male volunteers and/or healthy female volunteers of non-childbearing potential who are 18 to 55 years of age;
- Healthy volunteers with no evidence of active or latent or inadequately treated tuberculosis.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Clinical Research Unit
Brussels, B-1070, Belgium
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2015
First Posted
July 1, 2015
Study Start
June 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 19, 2015
Record last verified: 2015-08