Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.
NCT ID: NCT02624557
Last Updated: 2020-12-09
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
23 participants
INTERVENTIONAL
2015-12-21
2017-10-01
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
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Moderate hepatic impairment group
Subjects with moderate hepatic impairment with Child-Pugh score 7 - 9
Alpelisib
Subjects will receive a single dose of 300 mg alpelisib.
Severe hepatic impairment group
Subjects with severe hepatic impairment with Child-Pugh score 10 - 15
Alpelisib
Subjects will receive a single dose of 300 mg alpelisib.
Matching healthy control group
Subjects with apparent normal liver function matched to the hepatic impairment subjects by sex, race, age, and weight.
Alpelisib
Subjects will receive a single dose of 300 mg alpelisib.
Interventions
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Alpelisib
Subjects will receive a single dose of 300 mg alpelisib.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Smokers not willing to limit the use of tobacco to 10 cigarettes per day. -Surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject's safety in case of participation in the study. -Use of any herbal medications/supplements.
History of acute pancreatitis within 1 year of study entry.
Additional criteria for subjects with normal liver function:
-Use of any prescription or non-prescription medication. -Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
Additional criteria for hepatic impaired subjects: -Use of any prescription or non-prescription medication, that has the potential to interact with alpelisb. Concomitant medications without potential to interact with alpelisib must be stable in dose. -Encephalopathy grade 3 or worse. -Total bilirubin \> 6 mg/dl. Screening or baseline ECG: QTcF\>480msec for both genders
18 Years
75 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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DaVita Clinical Research-Denver
Lakewood, Colorado, United States
University of Miami / Clinical Research Services, Inc.
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Countries
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Related Links
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Results for CBYL719A2105 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CBYL719A2105
Identifier Type: -
Identifier Source: org_study_id