NCT01950481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2014

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2016

Enrollment Period

2.7 years

First QC Date

September 23, 2013

Last Update Submit

December 16, 2020

Conditions

Normal Hepatic FunctionImpaired Hepatic Function

Keywords

LDK378pharmacokineticshepatic impairment

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Number of subjects with Adverse events

    after informed consent is signed, 30 days after last dose

  • Plasma protein binding of LDK378

    Day 1 predose, Day 1 6 hours postdose

Study Arms (4)

Normal Hepatic Function

EXPERIMENTAL

Subjects with normal hepatic function

Drug: LDK378

Mild Hepatic Impairment

EXPERIMENTAL

Subjects with mild hepatic impairment

Drug: LDK378

Moderate Hepatic Impairment

EXPERIMENTAL

Subjects with moderate hepatic impairment

Drug: LDK378

Severe Hepatic Impairment

EXPERIMENTAL

Subjects with severe hepatic impairment

Drug: LDK378

Interventions

LDK378DRUG

Oral LDK378 750 mg once

Mild Hepatic ImpairmentModerate Hepatic ImpairmentNormal Hepatic FunctionSevere Hepatic Impairment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \- Subjects with confirmed cirrhosis

You may not qualify if:

  • impaired cardiac function
  • concurrent severe and/or uncontrolled medical conditions
  • Clinical evidence of severe ascites
  • Use of PPIs within 10 days prior to 2 days after LDK378 dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

DaVita Clinical Research-Denver

Lakewood, Colorado, 80228, United States

Location

Avail. Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Clinical Research of Miami, INC CLDK378A2110

Miami, Florida, 33126, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32086, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Related Links

MeSH Terms

Interventions

ceritinib

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 25, 2013

Study Start

January 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 19, 2020

Record last verified: 2016-12

Locations

US(5)