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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tofacitinib MR 22 mg (Fed); Drug: Tofacitinib MR 22 mg (Fasted)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02487433

2014-005056-26 (EudraCT Number)

A3921217

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Tofacitinib MR 22 mg Fed

Experimental group

Description:

Single dose of tofacitinib MR 22 mg administered under fed conditions

Treatment:

Drug: Tofacitinib MR 22 mg (Fed)

Tofacitinib MR 22 mg Fasted

Experimental group

Description:

Single dose of tofacitinib MR 22 mg administered under fasted conditions

Treatment:

Drug: Tofacitinib MR 22 mg (Fasted)