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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tofacitinib MR 22 mg (Fed); Drug: Tofacitinib MR 22 mg (Fasted)

• Registration Number: NCT02487433
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-23
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-29
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Posted: 2015-07-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tofacitinib MR 22 mg Fed	Tofacitinib MR 22 mg (Fed)	Single dose of tofacitinib MR 22 mg administered under fed conditions
Tofacitinib MR 22 mg Fasted	Tofacitinib MR 22 mg (Fasted)	Single dose of tofacitinib MR 22 mg administered under fasted conditions

Primary Outcome Measures

Name	Time	Method
AUC inf	48 hours post dose	Area under the plasma concentration-time profile from time zero to infinity (AUCinf).
AUC last	48 hours post dose	Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).
Cmax	48 hours post dose	Maximum observed plasma concentration (Cmax).

Secondary Outcome Measures

Name	Time	Method
Plasma Decay Half-Life (t 1/2)	48 hours post dose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time to Reach Maximum Observed Plasma Concentration (Tmax)	48 hours post dose

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium