Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment

Novartis

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: LCQ908

Study type: Interventional

Funder types: Industry

Identifiers

NCT01594957

CLCQ908B2101

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 3 patient groups

LCQ908 (mild hepatic impairment plus healthy volunteers)

Experimental group

Description:

Healthy subjects will be matched pair-wise by, sex, race, age (±10 years) and weight (±20%) to subjects with mild hepatic impairment and will receive a single dose of LCQ908.

Treatment:

Drug: LCQ908

LCQ908 (moderate hepatic impairment plus healthy volunteers)

Experimental group

Description:

Healthy subjects will be matched pair-wise by, sex, race, age (±10 years) and weight (±20%) to subjects with moderate hepatic impairment and will receive a single dose of LCQ908.

Treatment:

Drug: LCQ908

LCQ908 (severe hepatic impairment plus healthy volunteers)

Experimental group

Description:

Healthy subjects will be matched pair-wise by, sex, race, age (±10 years) and weight (±20%) to subjects with severe hepatic impairment and will receive a single dose of LCQ908.

Treatment:

Drug: LCQ908