Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2009-02-28
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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One
PH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state
Two
PH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fed state
Three
PH797804
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fasted state
Four
PH797804
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fed state
Interventions
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PH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fasted state
PH797804
Single oral dose of 5mg PH797804 as a powder in capsule formulation in the fed state
PH797804
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fasted state
PH797804
Single oral dose of 5mg PH797804 as an immediate release tablet formulation in the fed state
Eligibility Criteria
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Inclusion Criteria
* Healthy is defined as no clinical relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests
* Willing to use acceptable methods of contraception as outlined in the study protocol
* Body mass index between 18 to 30 kg/m2
* Subjects who are willing and able to comply with the scheduled visits, treatment plan and other study procedures
Exclusion Criteria
* Pregnant or nursing females
* Females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to the first dose until day 15 of period 4
* Subjects with conditions possibly affecting drug absorption (eg gastrectomy)
* A positive approved immunoassay/ELISA blood test for TB
* Subjects with a history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men
* Subjects who have use prescription or nonprescription drugs, vitamins and/or dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
* Subjects who have been administered medications capable of inducing hepatic enzyme metabolism (eg barbiturates, rifampin, carbamazepine, phenytoin or primidone) within 14 days (or 5 half-lives of the inducing agent, whichever is longer) of day 1 or within 28 days of administration of St John's wort
21 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6631025
Identifier Type: -
Identifier Source: org_study_id
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