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OpenTrials
Completed

NCT Number: NCT01950481

Effect of Hepatic Impairment on LDK378 Pharmacokinetics

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

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Key information

Conditions

Normal Hepatic Function Impaired Hepatic Function

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DaVita Clinical Research-Denver, Lakewood, Colorado, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LDK378

Drug

Oral LDK378 750 mg once

Primary outcomes

  1. LDK378 pharmacokinetic parameters (Tmax)

    Time frame: 18 Days

    Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects

  2. LDK378 pharmacokinetic parameters ( Cmax)

    Time frame: 18 Days

    Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects

  3. LDK378 pharmacokinetic parameters ( AUClast)

    Time frame: 18 Days

    Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects

  4. LDK378 pharmacokinetic parameters (AUCinf)

    Time frame: 18 Days

    Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects

  5. LDK378 pharmacokinetic parameters (T1/2)

    Time frame: 18 Days

    Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects

  6. LDK378 pharmacokinetic parameters (CL/F)

    Time frame: 18 Days

    Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects

  7. LDK378 pharmacokinetic parameters (Vz/F)

    Time frame: 18 Days

    Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects

Secondary outcomes

  1. Number of subjects with Adverse events

    Time frame: 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.

  2. Plasma protein binding of LDK378

    Time frame: Day 1 predose, Day 1 6 hours postdose

    Plasma protein binding of LDK378

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2013
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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