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Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects

NCT ID: NCT03681457

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-24

Study Completion Date

2019-09-25

Brief Summary

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The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic exposure of tropifexor and to evaluate the safety of tropifexor in subjects with hepatic impairment. The results of this study will support treatment and dosing decisions for patients with varying degrees of hepatic impairment.

Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease

Keywords

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LJN452 tropifexor PK safety healthy subjects hepatically impaired Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease NAFLD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 - Normal Hepatic Function

Normal hepatic function - Control - control group

Group Type OTHER

LJN452

Intervention Type DRUG

Dose A single dose

Group 2 - Mild Hepatic Impairment

Mild hepatic impairment - Child-Pugh A (Score 5-6)

Group Type EXPERIMENTAL

LJN452

Intervention Type DRUG

Dose A single dose

Group 3 - Moderate Hepatic Impairment

Moderate hepatic impairment - Child-Pugh B (Score 7-9)

Group Type EXPERIMENTAL

LJN452

Intervention Type DRUG

Dose A single dose

Group 4 - Severe Hepatic Impairment

Severe hepatic impairment - Child-Pugh C (score 10-15)

Group Type EXPERIMENTAL

LJN452

Intervention Type DRUG

Dose A single dose

Interventions

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LJN452

Dose A single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must weight at least 50 kg, with a BMI within the range of 18 to 38 kg/m2
* Must be willing to remain in the clinical research unit as required by the protocol


\- In good health as determined by past medical history, physical examination, ECG, laboratory tests, and urinalysis at Screening.


\- Hepatic impairment as defined by the Child-Pugh classification for severity of liver disease

Exclusion Criteria

* Use of other study drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations
* History of hypersensitivity to the study treatment or to drugs of similar chemical classes
* Pregnant or nursing women
* Women of child-bearing potential

Healthy Volunteers:


* Liver disease or liver injury
* Chronic infection with Hepatitis B or Hepatitis C
* History or presence of impaired renal function

Hepatically Impaired Subjects:


* Severe complications of liver disease within the preceding 3 months
* Emergency room visit or hospitalization due to liver disease within the preceding 3 months for mildly and moderately hepatically impaired subjects, and within the preceding 1 month for severely hepatically impaired subjects
* Subject has received liver transplant at any time in the past and is on immunosuppressant therapy
* Acute Hepatitis B or Hepatitis C infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Orlando, Florida, United States

Site Status

Novartis Investigative Site

Orlando, Florida, United States

Site Status

Novartis Investigative Site

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17722

Results for CCLJN452A2109 can be found on the Novartis Clinical Trial Results Website

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=555

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

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CLJN452A2109

Identifier Type: -

Identifier Source: org_study_id