NCT01670734

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_1

Geographic Reach
2 countries

2 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

August 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

8 months

First QC Date

August 16, 2012

Last Update Submit

June 27, 2013

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

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

    Up to 12 weeks

Secondary Outcomes (7)

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

    Up to 12 weeks

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

    Up to 12 weeks

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

    Up to 12 weeks

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

    Up to 12 weeks

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

    Up to 12 weeks

  • +2 more secondary outcomes

Study Arms (3)

alirocumab SAR236553 (REGN727) - mild hepatic function

EXPERIMENTAL

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

Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) - moderate hepatic function

EXPERIMENTAL

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

Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) - normal hepatic function

EXPERIMENTAL

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

Drug: alirocumab SAR236553 (REGN727)

Interventions

alirocumab SAR236553 (REGN727)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) - mild hepatic functionalirocumab SAR236553 (REGN727) - moderate hepatic functionalirocumab SAR236553 (REGN727) - normal hepatic function

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigational Site Number 250001

Rennes, 35000, France

Location

Investigational Site Number 498001

Chisinau, 2025, Moldova

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

alirocumab

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 22, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 28, 2013

Record last verified: 2013-06

Locations

MO(1)FR(1)