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Completed

NCT Number: NCT02084875

A Study To Evaluate The Effect Of Food On The Behavior Of Tofacitinib Modified Release 11 Milligram Tablets In Healthy Western And Japanese Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

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 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

Treatment and study plan

tofacitinib modified-release (MR) formulation

Drug

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

Primary outcomes

  1. Area under the curve from time zero to infinity

    Time frame: 48 hours post dose

    Area under the curve from time zero to infinity

  2. Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration

    Time frame: 48 hours post dose

    Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration

  3. Maximum Observed Plasma Concentration (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

    Time to peak concentration

  2. Plasma Decay Half-Life (t1/2)

    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) 11 Mg Tablets In Healthy Western And Japanese Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 12, 2014
Registry last updated
Nov 30, 2018

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.

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