Effect of Hepatic Impairment on LDK378 Pharmacokinetics

Novartis

Status and phase: Completed; Phase 1

Conditions: Impaired Hepatic Function; Normal Hepatic Function

Treatments: Drug: LDK378

Study type: Interventional

Funder types: Industry

Identifiers

NCT01950481

CLDK378A2110

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

Normal Hepatic Function

Experimental group

Description:

Subjects with normal hepatic function

Treatment:

Drug: LDK378

Mild Hepatic Impairment

Experimental group

Description:

Subjects with mild hepatic impairment

Treatment:

Drug: LDK378

Moderate Hepatic Impairment

Experimental group

Description:

Subjects with moderate hepatic impairment

Treatment:

Drug: LDK378

Severe Hepatic Impairment

Experimental group

Description:

Subjects with severe hepatic impairment

Treatment:

Drug: LDK378