Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.