Clinical trial NCT01277991: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis, Rheumatoid
Keywords: Bioequivalence
healthy volunteer study
Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PK parameters: AUCinf, AUClast and Cmax of CP-690,550
timeFrame: PK blood samples out to 24 hours post dose in each period
Secondary outcomes:
measure: PK parameters: Tmax, AUCt and half-life of CP-690,550
timeFrame: Derived from PK blood samples out to 24 hours post dose in each period
measure: Safety: laboratory tests
timeFrame: Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period
measure: Safety: vital signs
timeFrame: Prior to dosing in each period and at 24 hours post last dose in Period 2
measure: Safety: adverse event reporting
timeFrame: Throughout study
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: