A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Treatment C; Drug: Treatment A; Drug: Treatment B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01184092

A3921075

Details and patient eligibility

About

In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.

Full description

This is a pivotal bioequivalence study for tasocitinib (CP-690,550).

Enrollment: 24 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males>50 kg (110 lbs). For females, total body weight >45 kg (99 lbs).
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

Exclusion criteria

• Evidence of any clinically significant illness, medical condition, or disease.
• Evidence or history of any clinically significant infections within the past 3 months.
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Trial design

24 participants in 6 patient groups

Sequence 1

Experimental group

Treatment:

Drug: Treatment A

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment C

Drug: Treatment A

Drug: Treatment C

Drug: Treatment B

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment B

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment A

Drug: Treatment A

Sequence 2

Experimental group

Treatment:

Drug: Treatment A

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment C

Drug: Treatment A

Drug: Treatment C

Drug: Treatment B

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment B

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment A

Drug: Treatment A

Sequence 3

Experimental group

Treatment:

Drug: Treatment A

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment C

Drug: Treatment A

Drug: Treatment C

Drug: Treatment B

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment B

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment A

Drug: Treatment A

Sequence 4

Experimental group

Treatment:

Drug: Treatment A

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment C

Drug: Treatment A

Drug: Treatment C

Drug: Treatment B

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment B

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment A

Drug: Treatment A

Sequence 5

Experimental group

Treatment:

Drug: Treatment A

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment C

Drug: Treatment A

Drug: Treatment C

Drug: Treatment B

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment B

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment A

Drug: Treatment A

Sequence 6

Experimental group

Treatment:

Drug: Treatment A

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment C

Drug: Treatment A

Drug: Treatment C

Drug: Treatment B

Drug: Treatment B

Drug: Treatment A

Drug: Treatment B

Drug: Treatment B

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment C

Drug: Treatment A

Drug: Treatment A