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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487433
• Other study ID #: A3921217
• Secondary ID: 2014-005056-26
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2015
• Last updated: August 17, 2015
• Start date: June 2015
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tofacitinib MR 22 mg (Fed)
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)
A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC inf	Area under the plasma concentration-time profile from time zero to infinity (AUCinf).	48 hours post dose	No
Primary	AUC last	Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).	48 hours post dose	No
Primary	Cmax	Maximum observed plasma concentration (Cmax).	48 hours post dose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		48 hours post dose	No
Secondary	Plasma Decay Half-Life (t 1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	48 hours post dose	No