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Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects

NCT ID: NCT01670734

Last Updated: 2013-06-28

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-05-31

Brief Summary

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Primary Objective:

Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).

Secondary Objectives:

* Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.
* Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with hepatic impairment and in matched subjects with normal hepatic function.

Detailed Description

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Total duration of the study per subject (excluding screening) is about 12 weeks.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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alirocumab SAR236553 (REGN727) - mild hepatic function

Injection through subcutaneous (SC) administration in patients with mild hepatic function

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

alirocumab SAR236553 (REGN727) - moderate hepatic function

Injection through subcutaneous (SC) administration in patients with moderate hepatic function

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

alirocumab SAR236553 (REGN727) - normal hepatic function

Injection through subcutaneous (SC) administration in patients with normal hepatic function

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Interventions

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alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, between 18 to 75 years of age, inclusive.
* Patients with mild and moderate hepatic impairment based on Child-Pugh score and stable chronic liver disease.
* Healthy subjects with normal hepatic function.

Exclusion Criteria

* Patients with acute hepatitis, hepatic encephalopathy grade 2, 3, and 4.
* Patients with history or presence of uncontrolled clinically relevant illness.
* Healthy subjects with history or presence of clinically relevant illness.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 250001

Rennes, , France

Site Status

Investigational Site Number 498001

Chisinau, , Moldova

Site Status

Countries

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France Moldova

Other Identifiers

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2012-002292-33

Identifier Type: -

Identifier Source: secondary_id

U1111-1129-0248

Identifier Type: OTHER

Identifier Source: secondary_id

POP12671

Identifier Type: -

Identifier Source: org_study_id