Skip to main content
OpenTrials
Completed

NCT Number: NCT01670734

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 250001, Rennes, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: Up to 12 weeks

Secondary outcomes

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

    Time frame: Up to 12 weeks

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

    Time frame: Up to 12 weeks

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

    Time frame: Up to 12 weeks

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

    Time frame: Up to 12 weeks

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

    Time frame: Up to 12 weeks

  6. Pharmacodynamics: Change in LDL-C from baseline

    Time frame: Up to 12 weeks

  7. Number of participants with Adverse Events

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2012
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.