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Effect of Hepatic Impairment on LDK378 Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950481
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Normal Hepatic Function Impaired Hepatic Function Drug: LDK378 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ceritinib

Arm Intervention/treatment
Experimental: Normal Hepatic Function
Subjects with normal hepatic function
Drug: LDK378
Oral LDK378 750 mg once

Experimental: Mild Hepatic Impairment
Subjects with mild hepatic impairment
Drug: LDK378
Oral LDK378 750 mg once

Experimental: Moderate Hepatic Impairment
Subjects with moderate hepatic impairment
Drug: LDK378
Oral LDK378 750 mg once

Experimental: Severe Hepatic Impairment
Subjects with severe hepatic impairment
Drug: LDK378
Oral LDK378 750 mg once




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950481


Locations
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United States, Colorado
DaVita Clinical Research-Denver
Lakewood, Colorado, United States, 80228
United States, Florida
Avail. Clinical Research, LLC
Deland, Florida, United States, 32720
Clinical Research of Miami, INC CLDK378A2110
Miami, Florida, United States, 33126
Orlando Clinical Research Center
Orlando, Florida, United States, 32086
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01950481    
Other Study ID Numbers: CLDK378A2110
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: December 14, 2016
Last Verified: December 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
LDK378
pharmacokinetics
hepatic impairment
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Ceritinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action