Effect of Hepatic Impairment on LDK378 Pharmacokinetics

Impaired Hepatic Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950481
• Other study ID #: CLDK378A2110
• Status: Completed
• Phase: Phase 1
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Impaired Hepatic Function
• Liver Diseases
• Normal Hepatic Function

Intervention

Drug:
• LDK378
Oral LDK378 750 mg once

Locations

Country	Name	City	State
United States	Avail. Clinical Research, LLC	DeLand	Florida
United States	DaVita Clinical Research-Denver	Lakewood	Colorado
United States	Clinical Research of Miami, INC CLDK378A2110	Miami	Florida
United States	DaVita Clinical Research	Minneapolis	Minnesota
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDK378 pharmacokinetic parameters (Tmax)	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects	18 Days
Primary	LDK378 pharmacokinetic parameters ( Cmax)	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects	18 Days
Primary	LDK378 pharmacokinetic parameters ( AUClast)	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects	18 Days
Primary	LDK378 pharmacokinetic parameters (AUCinf)	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects	18 Days
Primary	LDK378 pharmacokinetic parameters (T1/2)	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects	18 Days
Primary	LDK378 pharmacokinetic parameters (CL/F)	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects	18 Days
Primary	LDK378 pharmacokinetic parameters (Vz/F)	Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects	18 Days
Secondary	Number of subjects with Adverse events	Safety will be determined by the frequency of adverse events and the frequency of laboratory toxicities.	after informed consent is signed, 30 days after last dose
Secondary	Plasma protein binding of LDK378	Plasma protein binding of LDK378	Day 1 predose, Day 1 6 hours postdose

External Links

•   Results for CLDK378A2110 can be found on the Novartis Clinical Trial Results Website