Healthy
Conditions
Keywords
Absolute Bioavailability, Rheumatoid Arthritis
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.
Detailed description
To estimate the absolute bioavailability of a 10 mg oral dose of tasocitinib (CP-690,550) compared to a 10 mg intravenous dose of tasocitinib (CP-690,550) in healthy subjects.
Interventions
DRUGTasocitinib 10 mg oral tablet
Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet
DRUGTasocitinib 10 mg IV Infusion
Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion
Sponsors
Pfizer
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 \>50 kg (110 lbs) * No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Exclusion criteria
* Evidence or history of any clinically significant illness, medical condition, or disease. 2\. Evidence or history of any clinically significant infections within the past 3 months. 3\. Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCinf of tasocitinib (CP 690,550) | PK blood samples out to 12 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Singapore
Outcome results
None listed