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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
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01143805
First received: June 9, 2010
Last updated: August 6, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Healthy | Drug: Tasocitinib 10 mg oral tablet Drug: Tasocitinib 10 mg IV Infusion | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) |
| Official Title: | A Phase 1, Open Label, Single Dose, Randomized, Cross Over Study To Estimate The Absolute Oral Bioavailability Of CP-690,550 In Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- AUCinf of tasocitinib (CP 690,550) [ Time Frame: PK blood samples out to 12 hours post dose ]
Secondary Outcome Measures:
- AUClast, Cmax, Tmax, and t½, CL (IV dose only) and Vss (IV dose only) of tasocitinib (CP 690,550). [ Time Frame: PK blood samples out to 12 hours postdose ]
- Safety Laboratory tests: hematology, chemistry, urine testing [ Time Frame: Safety Laboratory testing performed out to 2 days post last dose ]
- Vital Signs: Blood pressure, heart rate, oral temperature [ Time Frame: Vital signs out to 2 days post last dose ]
- AE Reporting [ Time Frame: Throughout study ]
| Enrollment: | 12 |
| Study Start Date: | July 2010 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment A: Tasocitinib 10 mg oral tablet |
Drug: Tasocitinib 10 mg oral tablet
Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet
|
| Experimental: Treatment B: Tasocitinib 10 mg IV Infusion |
Drug: Tasocitinib 10 mg IV Infusion
Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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 >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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01143805
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143805
Locations
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 188770 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01143805 History of Changes |
| Other Study ID Numbers: |
A3921077 |
| Study First Received: | June 9, 2010 |
| Last Updated: | August 6, 2010 |
Keywords provided by Pfizer:
|
Absolute Bioavailability Rheumatoid Arthritis |
Additional relevant MeSH terms:
|
Tofacitinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 21, 2017