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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277991
• Other study ID #: A3921135
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2011
• Last updated: April 6, 2011
• Start date: February 2011
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 .

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis, Rheumatoid

Intervention

Drug:
• Treatment A
Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)
• Treatment B
Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
• Treatment B
Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
• Treatment A
Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters: AUCinf, AUClast and Cmax of CP-690,550		PK blood samples out to 24 hours post dose in each period	No
Secondary	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	No
Secondary	Safety: laboratory tests		Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in each period	Yes
Secondary	Safety: vital signs		Prior to dosing in each period and at 24 hours post last dose in Period 2	Yes
Secondary	Safety: adverse event reporting		Throughout study	Yes

External Links

•   To obtain contact information for a study center near you, click here.