A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: tofacitinib (CP-690,550) modified-release formulation A; Drug: tofacitinib (CP-690,550) modified-release formulation B2; Drug: tofacitinib (CP-690,550) modified-release formulation B1; Drug: tofacitinib (CP-690,550) immediate-release formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01499004

A3921131

Details and patient eligibility

About

This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.

Enrollment: 30 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects and/or healthy females 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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30 participants in 6 patient groups

Treatment A

Experimental group

Description:

tofacitinib (CP-690,550) modified-release formulation A-Fed

Treatment:

Drug: tofacitinib (CP-690,550) modified-release formulation A

Drug: tofacitinib (CP-690,550) modified-release formulation A

Treatment B

Experimental group

Description:

tofacitinib (CP-690,550) modified-release formulation B1-Fed

Treatment:

Drug: tofacitinib (CP-690,550) modified-release formulation B1

Drug: tofacitinib (CP-690,550) modified-release formulation B1

Treatment C

Experimental group

Description:

tofacitinib (CP-690,550) modified-release formulation A-Fasted

Treatment:

Drug: tofacitinib (CP-690,550) modified-release formulation A

Drug: tofacitinib (CP-690,550) modified-release formulation A

Treatment D

Experimental group

Description:

tofacitinib (CP-690,550) modified-release formulation B1-Fasted

Treatment:

Drug: tofacitinib (CP-690,550) modified-release formulation B1

Drug: tofacitinib (CP-690,550) modified-release formulation B1

Treatment E

Experimental group

Description:

tofacitinib (CP-690,550) modified-release formulation B2-Fasted

Treatment:

Drug: tofacitinib (CP-690,550) modified-release formulation B2

Treatment F

Experimental group

Description:

tofacitinib (CP-690,550) immediate-release formulation-Fasted

Treatment:

Drug: tofacitinib (CP-690,550) immediate-release formulation