Effect of Hepatic Impairment on LDK378 Pharmacokinetics

Phase 1

Completed

• Conditions: Normal Hepatic Function; Impaired Hepatic Function
• Interventions: Drug: LDK378

• Registration Number: NCT01950481
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-25
• Study Start: 2014-01
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe Hepatic Impairment	LDK378	Subjects with severe hepatic impairment
Normal Hepatic Function	LDK378	Subjects with normal hepatic function
Mild Hepatic Impairment	LDK378	Subjects with mild hepatic impairment
Moderate Hepatic Impairment	LDK378	Subjects with moderate hepatic impairment

Primary Outcome Measures

Name	Time	Method
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 (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 (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 (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 (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 (AUCinf)	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

Secondary Outcome Measures

Name	Time	Method
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.
Plasma protein binding of LDK378	Day 1 predose, Day 1 6 hours postdose	Plasma protein binding of LDK378

Trial Locations

Locations (5)

DaVita Clinical Research-Denver; 🇺🇸 Lakewood, Colorado, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Avail. Clinical Research, LLC; 🇺🇸 DeLand, Florida, United States

Clinical Research of Miami, INC CLDK378A2110; 🇺🇸 Miami, Florida, United States

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States