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

NCT02084875 | Completed Phase 1

• 1 other identifier: A3921180
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Food effect; pharmacokinetic; healthy volunteer

Outcome Measures

Primary Outcomes (3)

• Area under the curve from time zero to infinity

  Area under the curve from time zero to infinity

  48 hours post dose

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

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

  48 hours post dose

• Maximum Observed Plasma Concentration (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 (t1/2)

  48 hours post dose

Study Arms (2)

tofacitinib MR 11 mg Fed

EXPERIMENTAL

tofacitinib modified release (MR) 11 mg tablet administered with food.

Drug: tofacitinib modified-release (MR) formulation

tofacitinib MR 11 mg Fasting

EXPERIMENTAL

tofacitinib modified release (MR) 11 mg tablet administered without food.

Drug: tofacitinib modified-release (MR) formulation

Interventions

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.

tofacitinib MR 11 mg Fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: March 10, 2014
• First Posted: March 12, 2014
• Study Start: April 11, 2014
• Primary Completion: May 25, 2014
• Study Completion: May 25, 2014
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

US (1)