Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects
NCT ID: NCT01459250
Last Updated: 2020-12-08
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
32 participants
INTERVENTIONAL
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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AGO178C
AGO178C
Interventions
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AGO178C
Eligibility Criteria
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Inclusion Criteria
* Healthy male or female subjects to match renally impaired patients in BMI (±15%), age (± 7 years) and gender (in this order). Smoking status (yes or no) will also be used as a final criterion, if deemed feasible by the Investigator.
Exclusion Criteria
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study as defined in the protocol.
* Smokers, smoking 10 cigarettes or more per day from screening to study completion
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
* Co-medication for healthy subjects
18 Years
79 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Minneapolis, Minnesota, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Countries
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Related Links
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Results for CAGO178C2104 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CAGO178C2104
Identifier Type: -
Identifier Source: org_study_id