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Clareo Health | Effect of Hepatic Impairment on LDK378 Pharmacokinetics

Effect of Hepatic Impairment on LDK378 Pharmacokinetics

NCT01950481·5 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

Novartis Pharmaceuticals

Age

18–70

Sex

ALL

Healthy volunteers

Accepted

You may be eligible if

Male Subjects between 18-70 years of age
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

You may not be if

impaired cardiac function
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

The record

StatusCompleted

PhasePhase 1

Taking part36

StartedJan 2014

UpdatedDec 19, 2020

Conditions

Normal Hepatic Function Impaired Hepatic Function

Where5

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