Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011

Completed · Phase 1

Conditions studied: Normal Hepatic Function, Impaired Hepatic Function

In brief

The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic function.

Key facts

Study ID

NCT02388620

Run by

Novartis Pharmaceuticals

People needed

30

Starts

2015-03-25

Expected to finish

2017-01-09

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All Subjects:
• 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.
• Other than hepatic impairment, subjects must be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, (except for additional inclusion criteria described below).
• Subjects in Child-Pugh A, B and C cohorts: Additional inclusion criteria
• 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).

You may not qualify if…

• All Subjects:
• 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:
• Additional exclusion criteria A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
• Subjects in Child-Pugh A, B and C cohorts:
• Additional exclusion criteria
• Clinical evidence of severe ascites (e.g. requiring regular tapping).
• Bilirubin > 6 mg/dL

Where it is running

• Anaheim Clinical Trials — Anaheim, California, United States
• University of Miami — Coral Gables, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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