A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: tofacitinib modified-release (MR) formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01731327

A3921132

Details and patient eligibility

About

This study will explore the drug behavior and safety following single doses of tofacitinib modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.

Enrollment: 20 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects and/or healthy female subjects who are of non-childbearing potential.

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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20 participants in 2 patient groups

Experimental Treatment A

Experimental group

Description:

A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.

Treatment:

Drug: tofacitinib modified-release (MR) formulation

Drug: tofacitinib modified-release (MR) formulation

Experimental Treatment B

Experimental group

Description:

A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.

Treatment:

Drug: tofacitinib modified-release (MR) formulation

Drug: tofacitinib modified-release (MR) formulation