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

NCT01277991 | Completed Phase 1

• 1 other identifier: A3921135
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 .

Conditions

Arthritis, Rheumatoid

Keywords

Bioequivalence; healthy volunteer study; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• PK parameters: AUCinf, AUClast and Cmax of CP-690,550

  PK blood samples out to 24 hours post dose in each period

Secondary Outcomes (4)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

Drug: Treatment A; Drug: Treatment B

Sequence 2

EXPERIMENTAL

Drug: Treatment B; Drug: Treatment A

Interventions

Treatment A DRUG

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

Sequence 1

Treatment B DRUG

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

Sequence 1

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 17, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 7, 2011

Record last verified: 2011-04

Locations

SG (1)