A Study To Compare The Amount Of CP-690,550 That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Two Different Strength Tablets Of CP-690,550

Phase 1, Open-label, Randomized, Single-dose, 2-treatment, 2-period, Crossover, Bioequivalence Study Comparing Phase 2b 1 Mg And 5 Mg Tablet Formulations Of Cp-690,550 Under Fasted Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01277991

Enrollment

Registered

2011-01-17

Start date

2011-02-28

Completion date

2011-03-31

Last updated

2011-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Bioequivalence, healthy volunteer study, Rheumatoid Arthritis

Brief summary

In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate occasions using one of two different strength tablets each time. The amount of CP-690,550 available in the blood following administration of each tablet will be measured and compared. The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed into the blood following administration of the same dose of each different strength tablet .

Detailed description

This is a bioequivalence study for CP-690,550.

Interventions

DRUGTreatment A

Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)

DRUGTreatment B

Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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 \>45 kg (99 lbs). * No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

Exclusion criteria

Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Personal or family history of hereditary immunodeficiency (eg, severe - 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.

Design outcomes

Primary

Measure	Time frame
PK parameters: AUCinf, AUClast and Cmax of CP-690,550	PK blood samples out to 24 hours post dose in each period

Secondary

Measure	Time frame
PK parameters: Tmax, AUCt and half-life of CP-690,550	Derived from PK blood samples out to 24 hours post dose in each period
Safety: laboratory tests	Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period
Safety: vital signs	Prior to dosing in each period and at 24 hours post last dose in Period 2
Safety: adverse event reporting	Throughout study

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026