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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02487433

Enrollment

Registered

2015-07-01

Start date

2015-06-30

Completion date

2015-07-31

Last updated

2015-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

food effect, pharmacokinetics, healthy volunteers

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.

Interventions

DRUGTofacitinib MR 22 mg (Fed)

A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal

DRUGTofacitinib MR 22 mg (Fasted)

A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

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

Design outcomes

Primary

Measure	Time frame	Description
AUC inf	48 hours post dose	Area under the plasma concentration-time profile from time zero to infinity (AUCinf).
AUC last	48 hours post dose	Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).
Cmax	48 hours post dose	Maximum observed plasma concentration (Cmax).

Secondary

Measure	Time frame	Description
Time to Reach Maximum Observed Plasma Concentration (Tmax)	48 hours post dose	—
Plasma Decay Half-Life (t 1/2)	48 hours post dose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026