A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)
NCT ID: NCT01934738
Last Updated: 2014-03-11
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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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2013-10-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Group 1: Cohort 1
PF-06273340
Tablets, 100 mg TID, 14 days
Placebo
Tablets, TID, 14 days
Group 1: Cohort 2
PF-06273340
Tablets, to be decided dose, TID or titration, 14 days
Placebo
Tablets, TID or titration, 14 days
Group 1: Cohort 3
PF-06273340
Tablets, to be decided dose, TID or titration, 14 days
Placebo
Tablets, TID or titration, 14 days
Group 2: Cohort 4
PF-06273340
Tablets, to be decided dose, TID or titration, 14 days
Placebo
Tablets, TID or titration, 14 days
Group 1: Cohort 5
PF-06273340
Tablets, to be decided dose, TID or titration, 14 days
Placebo
Tablets, TID or titration, 14 days
Group 2: Cohort 6
PF-06273340
Tablets, to be decided dose, TID or titration, 14 days
Placebo
Tablets, TID or titration, 14 days
Interventions
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PF-06273340
Tablets, 100 mg TID, 14 days
Placebo
Tablets, TID, 14 days
PF-06273340
Tablets, to be decided dose, TID or titration, 14 days
Placebo
Tablets, TID or titration, 14 days
PF-06273340
Tablets, to be decided dose, TID or titration, 14 days
Placebo
Tablets, TID or titration, 14 days
PF-06273340
Tablets, to be decided dose, TID or titration, 14 days
Placebo
Tablets, TID or titration, 14 days
PF-06273340
Tablets, to be decided dose, TID or titration, 14 days
Placebo
Tablets, TID or titration, 14 days
PF-06273340
Tablets, to be decided dose, TID or titration, 14 days
Placebo
Tablets, TID or titration, 14 days
Eligibility Criteria
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Inclusion Criteria
* For Group 2 specific: Healthy male and/or female subjects of non-childbearing potential between the ages of 56 and 75 years, inclusive. Subjects must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the osteoarthritis (OA) population, at least 50% of the subjects enrolled in these cohorts must be 60 years of age and above at Screening.
* For Group 2 specific: Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose of these, as defined by non change in dose for the 3 months prior to the first dose of study medication and no planned changes during the conduct of the study.
Exclusion Criteria
* Any condition possibly affecting drug absorption (eg, gastrectomy).
18 Years
75 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Brussels, , Belgium
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B5261002
Identifier Type: -
Identifier Source: org_study_id
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