Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011
NCT ID: NCT02388620
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
30 participants
INTERVENTIONAL
2015-03-25
2017-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Normal Hepatic Function
Normal hepatic function; matched demography to hepatic impairment cohorts
LEE011
400 mg
Mild Hepatic Impairment
Child-Pugh Classification A (score 5-6)
LEE011
400 mg
Moderate Hepatic Impairment
Child-Pugh Classification B (score 7-9)
LEE011
400 mg
Severe Hepatic Impairment
Child-Pugh Classification C (score 10-15)
LEE011
400 mg
Interventions
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LEE011
400 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Male or female (sterile or postmenopausal) subjects between 18-75 (both inclusive) years of age and healthy as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations.
Subjects must have a BMI between 18 kg/m2 and 36 kg/m2 and weight at least 50 kg and no more than 120 kg.
Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment
No change in hepatic status at least one month prior to dosing (i.e. worsening of Child-Pugh score).
Exclusion Criteria
Subject has received a liver transplant at any time in the past and is on immunosuppressant therapy.
History or presence of impaired cardiac function
Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism or excretion of drugs
Administration of CYP3A4/5 inhibitors or inducers or CYP3A4 substrates with narrow therapeutic windows
Administration of medications that prolong the QT interval
History of immunodeficiency diseases, including HIV, as confirmed by (HIV-1, HIV-2) test.
Participation in another clinical trial within 4 weeks prior to the study drug administration.
Subjects with normal hepatic function:
Subjects in Child-Pugh A, B and C cohorts:
Clinical evidence of severe ascites (e.g. requiring regular tapping).
Bilirubin \> 6 mg/dL
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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Anaheim Clinical Trials
Anaheim, California, United States
University of Miami
Coral Gables, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Countries
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References
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Samant TS, Yang S, Miller M, Ji Y. Pharmacokinetics of Ribociclib in Subjects With Hepatic Impairment. J Clin Pharmacol. 2021 Aug;61(8):1001-1009. doi: 10.1002/jcph.1825. Epub 2021 Mar 12.
Related Links
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Results for CLEE011A2109 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CLEE011A2109
Identifier Type: -
Identifier Source: org_study_id