Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:5/27/2013
Start Date:April 2012
End Date:January 2013
Contact:Novartis Pharmaceuticals Study Director
Phone:862-778-8300

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An Open-label, Single Dose, Parallel-group Study to Evaluate the Pharmacokinetics of LCQ908 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared to Age, Gender and Weight-matched Healthy Volunteers.


This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of
hepatic impairment to healthy subjects.


Inclusion criteria:

Individuals with hepatic impairment only

• Hepatic impairment evidenced by a Child-Pugh score

- Mild hepatic impairment defined Child-Pugh Class A (5-6 points)

- Moderate hepatic impairment defined Child-Pugh Class B (7-9 points)

- Severe hepatic impairment defined Child-Pugh Class C (10-15 points).

Healthy subjects only

• Good health determined.

Exclusion criteria:

All Individuals

- A past medical history of clinically significant ECG abnormalities or a family
history of a prolonged QT-interval syndrome.

- Female subjects must be of non child bearing potential or use an effective method of
contraception.

Individuals with hepatic impairment

- History of drug or alcohol abuse within 3 months prior to dosing.

- History or presence of significant uncontrolled disease of any major organ class.

- Any surgical or medical condition other than hepatic impairment which might alter the
drug metabolism.

Healthy subjects

- History or presence of significant uncontrolled disease of any major organ class.

- Any surgical or medical condition other than hepatic impairment which might alter the
drug metabolism.

- History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen
(HBsAg) or Hepatitis C test result at screening.

Other protocol-defined inclusion/exclusion criteria may apply.
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Miami, Florida 33136
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