Skip to main content
OpenTrials
Completed

NCT Number: NCT02487433

A Study To Evaluate The Effect Of Food On The Behavior of Tofacitinib Modified Release 22 Milligram Tablets In Healthy Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tofacitinib MR 22 mg (Fed)

Drug

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

Tofacitinib MR 22 mg (Fasted)

Drug

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

Primary outcomes

  1. AUC inf

    Time frame: 48 hours post dose

    Area under the plasma concentration-time profile from time zero to infinity (AUCinf).

  2. AUC last

    Time frame: 48 hours post dose

    Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).

  3. Cmax

    Time frame: 48 hours post dose

    Maximum observed plasma concentration (Cmax).

Secondary outcomes

  1. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 48 hours post dose

  2. Plasma Decay Half-Life (t 1/2)

    Time frame: 48 hours post dose

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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) 22 Mg Tablets In Healthy Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2015
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.