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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02084875

Enrollment

Registered

2014-03-12

Start date

2014-04-11

Completion date

2014-05-25

Last updated

2018-11-30

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

Conditions

Healthy

Keywords

Food effect, pharmacokinetic, healthy volunteer

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.

Interventions

DRUGtofacitinib modified-release (MR) formulation

A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.

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 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

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