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

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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
We found this trial at
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Lakewood, Colorado 80228
Principal Investigator: Chris Galloway
Phone: 303-566-3008
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Principal Investigator: John Hill
Phone: 386-785-2400
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825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
Principal Investigator: Jolene Berg
Phone: 612-347-6206
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
Principal Investigator: Thomas C. Marbury
Phone: 407-472-0228
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Orlando, FL
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