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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084875
• Other study ID #: A3921180
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2014
• Est. completion date: May 25, 2014

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 25, 2014
• Est. primary completion date: May 25, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• tofacitinib modified-release (MR) formulation
A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.
• tofacitinib modified-release (MR) formulation
tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.

Locations

Country	Name	City	State
United States	Glendale Adventist Medical Center	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve from time zero to infinity	Area under the curve from time zero to infinity	48 hours post dose
Primary	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
Primary	Maximum Observed Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration (Cmax)	48 hours post dose
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)	Time to peak concentration	48 hours post dose
Secondary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	48 hours post dose

External Links

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