Effect of Hepatic Impairment on LDK378 Pharmacokinetics

A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDK378 in Subjects With Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01950481

Enrollment

Registered

2013-09-25

Start date

2014-01-31

Completion date

2016-09-30

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impaired Hepatic Function, Normal Hepatic Function

Keywords

LDK378, pharmacokinetics, hepatic impairment

Brief summary

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

Interventions

DRUGLDK378

Oral LDK378 750 mg once

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
LDK378 pharmacokinetic parameters (Vz/F)	18 Days	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (T1/2)	18 Days	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (CL/F)	18 Days	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (Tmax)	18 Days	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters ( Cmax)	18 Days	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters ( AUClast)	18 Days	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects
LDK378 pharmacokinetic parameters (AUCinf)	18 Days	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects

Secondary

Measure	Time frame	Description
Plasma protein binding of LDK378	Day 1 predose, Day 1 6 hours postdose	Plasma protein binding of LDK378
Number of subjects with Adverse events	after informed consent is signed, 30 days after last dose	Safety will be determined by the frequency of adverse events and the frequency of laboratory toxicities.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026