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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

alirocumab SAR236553 (REGN727)

About this trial

This is an interventional basic science trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Investigational Site Number 250001
Investigational Site Number 498001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

alirocumab SAR236553 (REGN727) - mild hepatic function

alirocumab SAR236553 (REGN727) - moderate hepatic function

alirocumab SAR236553 (REGN727) - normal hepatic function

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)

Secondary Outcome Measures

Assessment of PK parameter - terminal elimination half-life (t1/2z) [

Assessment of PK parameter - apparent total body clearance (CL/F)

Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)

Assessment of PK parameter - time to maximum concentration (tmax)

Assessment of PK parameter - Mean Residence Time (MRT [area])

Pharmacodynamics: Change in LDL-C from baseline

Number of participants with Adverse Events

Full Information

NCT ID

NCT01670734

First Posted

August 16, 2012

Last Updated

June 27, 2013

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01670734

Brief Title

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

Official Title

An Open-Label, Pharmacokinetic and Tolerability Study of SAR236553/REGN727 Given as a Single SC Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

alirocumab SAR236553 (REGN727) - mild hepatic function

Arm Type

Experimental

Arm Description

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

Arm Title

alirocumab SAR236553 (REGN727) - moderate hepatic function

Arm Type

Experimental

Arm Description

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

Arm Title

alirocumab SAR236553 (REGN727) - normal hepatic function

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

alirocumab SAR236553 (REGN727)

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)

Time Frame

Up to 12 weeks

Secondary Outcome Measure Information:

Title

Assessment of PK parameter - terminal elimination half-life (t1/2z) [

Time Frame

Up to 12 weeks

Title

Assessment of PK parameter - apparent total body clearance (CL/F)

Time Frame

Up to 12 weeks

Title

Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)

Time Frame

Up to 12 weeks

Title

Assessment of PK parameter - time to maximum concentration (tmax)

Time Frame

Up to 12 weeks

Title

Assessment of PK parameter - Mean Residence Time (MRT [area])

Time Frame

Up to 12 weeks

Title

Pharmacodynamics: Change in LDL-C from baseline

Time Frame

Up to 12 weeks

Title

Number of participants with Adverse Events

Time Frame

Up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 250001

City

Rennes

ZIP/Postal Code

35000

Country

France

Facility Name

Investigational Site Number 498001

City

Chisinau

ZIP/Postal Code

2025

Country

Moldova, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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