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

Pfizer20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

tofacitinib modified-release (MR) formulationDRUG

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

tofacitinib modified-release (MR) formulationDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Singapore, Singapore, Singapore