Effect of Hepatic Impairment on LDK378 Pharmacokinetics

Phase 1CompletedNCT01950481

Novartis Pharmaceuticals36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Normal Hepatic Function Impaired Hepatic Function

Interventions

LDK378DRUG

Oral LDK378 750 mg once

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

DaVita Clinical Research-Denver

Lakewood, Colorado, United States

Avail. Clinical Research, LLC

DeLand, Florida, United States

Clinical Research of Miami, INC CLDK378A2110

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States