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A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects

NCT ID: NCT01456663

Last Updated: 2020-12-08

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

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-07-31

Brief Summary

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This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe hepatic impairment compared with healthy control subjects.

Detailed Description

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Conditions

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Hepatic Impairment

Keywords

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AFQ056 Hepatic impairment Hepatic impaired

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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AFQ056

Group Type EXPERIMENTAL

AFQ056

Intervention Type DRUG

Interventions

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AFQ056

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Groups 1, 2, 3 and 4 (all subjects)
* Male and female Caucasian subjects
* Group 1, 2 and 3 (subjects with hepatic impairment)
* Subjects must satisfy the criteria for hepatic impairment as evidenced by a Child-Pugh score of A, B or C at screening
* Group 4 (healthy subjects)
* Each healthy subject must match in age (±8 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1, 2 or 3.

Exclusion Criteria

* Groups 1, 2, 3 and 4 (all subjects)
* Use of any tobacco products from 1 week prior to cotinine screening assessments until study completion.
* Group 1, 2 and 3 (subjects with hepatic impairment)
* History of drug or alcohol abuse within 3 months prior to screening
* History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases within 1 month prior to study drug administration except for hepatic impairment or any other disease associated with this underlying condition.
* Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
* History or presence of encephalopathy within 6 months prior screening (except for subjects in Groups 2 and 3).
* Documented presence of a porto-systemic shunt.
* Documented presence of esophagus varices (stage III or IV).
* Group 4 (healthy subjects)
* History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study. History of drug or alcohol abuse within 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline.
* History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Orlando, Florida, United States

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Balatonfüred, , Hungary

Site Status

Countries

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Lithuania United States Germany Hungary

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9464

Results for CAFQ056A2123 can be found on the Novartis Clinical Trial Results website

Other Identifiers

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2011-000748-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAFQ056A2123

Identifier Type: -

Identifier Source: org_study_id