Effect of Hepatic Impairment on LDK378 Pharmacokinetics

Status:	Recruiting
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - 70
Updated:	4/21/2016
Start Date:	January 2014
End Date:	January 2017
Contact:	Novartis Pharmaceuticals
Phone:	1-888-669-6682

A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDK378 in Subjects With Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired
hepatic function and healthy subjects with normal hepatic function.

Inclusion Criteria (all groups):

- 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

Exclusion Criteria (all groups):

- impaired cardiac function

- concurrent severe and/or uncontrolled medical conditions

Exclusion Criteria (moderate, mild and severe groups):

- Clinical evidence of severe ascites

- Use of PPIs within 10 days prior to 2 days after LDK378 dosing

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