Effect of Hepatic Impairment on LDK378 Pharmacokinetics
NCT ID: NCT01950481
Last Updated: 2020-12-19
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
36 participants
INTERVENTIONAL
2014-01-31
2016-09-30
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
TREATMENT
NONE
Study Groups
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Normal Hepatic Function
Subjects with normal hepatic function
LDK378
Oral LDK378 750 mg once
Mild Hepatic Impairment
Subjects with mild hepatic impairment
LDK378
Oral LDK378 750 mg once
Moderate Hepatic Impairment
Subjects with moderate hepatic impairment
LDK378
Oral LDK378 750 mg once
Severe Hepatic Impairment
Subjects with severe hepatic impairment
LDK378
Oral LDK378 750 mg once
Interventions
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LDK378
Oral LDK378 750 mg once
Eligibility Criteria
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Inclusion Criteria
* Female subjects between 18-70 years of age who are postmenopausal or sterile
* Body Mass Index (BMI) of 18.0- 36.0 kg/m2, with body weight ≥ 50 kg.
Inclusion (group mild, moderate and severe hepatic impairment):
\- Subjects with confirmed cirrhosis
Exclusion Criteria
* concurrent severe and/or uncontrolled medical conditions
* Clinical evidence of severe ascites
* Use of PPIs within 10 days prior to 2 days after LDK378 dosing
18 Years
70 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
Avail. Clinical Research, LLC
DeLand, Florida, United States
Clinical Research of Miami, INC CLDK378A2110
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 CLDK378A2110 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CLDK378A2110
Identifier Type: -
Identifier Source: org_study_id