A Study To Estimate The Amount Of CP-690,550 (Study Drug) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of CP-690,550 In Tablet Form

NCT01143805 | Completed Phase 1

• 1 other identifier: A3921077
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, a 10 mg dose of CP-690,550 will be given to study subjects on two separate occasions by two different routes of administration: One time by mouth in tablet form and one time by vein (intravenous form). The amount of CP-690,550 available in the blood following administration by vein will be measured and is expected to reflect the maximum amount possible for the 10 mg CP-690,550 dose. The amount of CP-690,550 that is achieved in the blood following oral tablet administration will also be measured and compared to that achieved following administration by vein in order to estimate how much of the maximum amount possible is actually absorbed into the blood following administration by mouth as a tablet.

Conditions

Healthy

Keywords

Absolute Bioavailability; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• AUCinf of tasocitinib (CP 690,550)

  PK blood samples out to 12 hours post dose

Secondary Outcomes (4)

• AUClast, Cmax, Tmax, and t½, CL (IV dose only) and Vss (IV dose only) of tasocitinib (CP 690,550).

  PK blood samples out to 12 hours postdose

• Safety Laboratory tests: hematology, chemistry, urine testing

  Safety Laboratory testing performed out to 2 days post last dose

• Vital Signs: Blood pressure, heart rate, oral temperature

  Vital signs out to 2 days post last dose

• AE Reporting

  Throughout study

Study Arms (2)

Treatment A: Tasocitinib 10 mg oral tablet

EXPERIMENTAL

Drug: Tasocitinib 10 mg oral tablet

Treatment B: Tasocitinib 10 mg IV Infusion

EXPERIMENTAL

Drug: Tasocitinib 10 mg IV Infusion

Interventions

Tasocitinib 10 mg oral tablet DRUG

Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet

Treatment A: Tasocitinib 10 mg oral tablet

Tasocitinib 10 mg IV Infusion DRUG

Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion

Treatment B: Tasocitinib 10 mg IV Infusion

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 \>50 kg (110 lbs)
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

You may not qualify if:

• Evidence or history 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

Interventions

tofacitinib; Tablets; Infusions, Intravenous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

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: June 9, 2010
• First Posted: June 14, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 10, 2010

Record last verified: 2010-08

Locations

SG (1)